Trial Outcomes & Findings for Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix (NCT NCT00064077)

NCT ID: NCT00064077

Last Updated: 2018-10-17

Results Overview

Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 513 participants
• Primary outcome timeframe: Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)
• Results posted on: 2018-10-17

Participant Flow

From May 2003 through April 2007, 513 patients were enrolled. Interim analysis recommended early closure for futility in January 2004.

Until January 2004, the study consisted of only two arms. Interim analysis recommended early closure for futility. 41 patients were enrolled until that point. These 41 patients were excluded from analysis. Two more arms were added and the study re-opened with 4 arms. The 472 patients enrolled after 1/26/2004 were included in analysis.

Participant milestones

Measure	Arm I (Paclitaxel, Cisplatin) Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Vinorelbine, Cisplatin) Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Arm III (Gemcitabine, Cisplatin) Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Arm IV (Topotecan, Cisplatin) Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
Overall Study STARTED	118	117	119	118
Overall Study COMPLETED	103	108	112	111
Overall Study NOT COMPLETED	15	9	7	7

Reasons for withdrawal

Measure	Arm I (Paclitaxel, Cisplatin) Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Vinorelbine, Cisplatin) Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Arm III (Gemcitabine, Cisplatin) Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Arm IV (Topotecan, Cisplatin) Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
Overall Study Improper prior treatment	1	0	0	0
Overall Study Poor risk	2	0	1	1
Overall Study Pathology	10	7	3	4
Overall Study No surgery	0	0	1	0
Overall Study No tumor	0	0	1	0
Overall Study Other reasons	2	2	1	2

Baseline Characteristics

Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix

Baseline characteristics by cohort

Measure	Arm I (Paclitaxel, Cisplatin) n=103 Participants Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Vinorelbine, Cisplatin) n=108 Participants Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Arm III (Gemcitabine, Cisplatin) n=112 Participants Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Arm IV (Topotecan, Cisplatin) n=111 Participants Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV	Total n=434 Participants Total of all reporting groups
Age, Continuous	50 years n=5 Participants	49 years n=7 Participants	45 years n=5 Participants	48 years n=4 Participants	48 years n=21 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	108 Participants n=7 Participants	112 Participants n=5 Participants	111 Participants n=4 Participants	434 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants	19 Participants n=4 Participants	65 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	75 Participants n=5 Participants	90 Participants n=7 Participants	86 Participants n=5 Participants	78 Participants n=4 Participants	329 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants	40 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	17 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	20 Participants n=7 Participants	23 Participants n=5 Participants	17 Participants n=4 Participants	79 Participants n=21 Participants
Race (NIH/OMB) White	75 Participants n=5 Participants	79 Participants n=7 Participants	80 Participants n=5 Participants	82 Participants n=4 Participants	316 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	17 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)

Population: Evaluable (treatment)

Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

Outcome measures

Measure	Arm I (Paclitaxel, Cisplatin) n=103 Participants Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Vinorelbine, Cisplatin) n=108 Participants Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Arm III (Gemcitabine, Cisplatin) n=112 Participants Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Arm IV (Topotecan, Cisplatin) n=111 Participants Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
Duration of Overall Survival (OS)	12.87 months Interval 10.02 to 16.76	9.99 months Interval 8.25 to 12.25	10.28 months Interval 7.62 to 11.6	10.25 months Interval 8.61 to 11.66

SECONDARY outcome

Timeframe: Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)

Population: Evaluable (treatment)

RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above.

Outcome measures

Measure	Arm I (Paclitaxel, Cisplatin) n=103 Participants Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Vinorelbine, Cisplatin) n=108 Participants Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Arm III (Gemcitabine, Cisplatin) n=112 Participants Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Arm IV (Topotecan, Cisplatin) n=111 Participants Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
Frequency of Response Using RECIST Version 1.0 Complete Response	3 Participants	8 Participants	1 Participants	2 Participants
Frequency of Response Using RECIST Version 1.0 Partial Response	27 Participants	20 Participants	24 Participants	24 Participants
Frequency of Response Using RECIST Version 1.0 Stable Disease	50 Participants	46 Participants	54 Participants	53 Participants
Frequency of Response Using RECIST Version 1.0 Progressive Disease/other	23 Participants	34 Participants	33 Participants	32 Participants

SECONDARY outcome

Timeframe: Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)

Population: Evaluable (treatment)

Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

Outcome measures

Measure	Arm I (Paclitaxel, Cisplatin) n=103 Participants Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Vinorelbine, Cisplatin) n=108 Participants Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Arm III (Gemcitabine, Cisplatin) n=112 Participants Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Arm IV (Topotecan, Cisplatin) n=111 Participants Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
Duration of Progression-free Survival (PFS)	5.82 months Interval 4.53 to 7.59	3.98 months Interval 3.19 to 5.16	4.70 months Interval 3.58 to 5.59	4.57 months Interval 3.71 to 5.75

SECONDARY outcome

Timeframe: Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

Population: Patients who provided baseline and ≥ one follow-up assessments

The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL.

Outcome measures

Measure	Arm I (Paclitaxel, Cisplatin) n=86 Participants Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Vinorelbine, Cisplatin) n=89 Participants Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Arm III (Gemcitabine, Cisplatin) n=92 Participants Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Arm IV (Topotecan, Cisplatin) n=96 Participants Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) Baseline	66.6 units on a scale Standard Deviation 17.6	69.1 units on a scale Standard Deviation 18.6	67.9 units on a scale Standard Deviation 19.5	68.1 units on a scale Standard Deviation 19.2
Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) Pre-cycle 2	65.2 units on a scale Standard Deviation 17.6	65.5 units on a scale Standard Deviation 15.8	65.3 units on a scale Standard Deviation 18.2	66.2 units on a scale Standard Deviation 16.3
Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) Pre-cycle 5	70.5 units on a scale Standard Deviation 16.5	66.6 units on a scale Standard Deviation 17.4	64.5 units on a scale Standard Deviation 16.5	68.4 units on a scale Standard Deviation 15.5
Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) 9 months post cycle 1	71.9 units on a scale Standard Deviation 16.6	69.9 units on a scale Standard Deviation 18.8	68.6 units on a scale Standard Deviation 19.5	70.9 units on a scale Standard Deviation 17.9

SECONDARY outcome

Timeframe: Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

Population: Patients who provided baseline and ≥ one follow-up assessments

Single item from the Brief Pain Inventory (BPI) assessing "worst pain" in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score.

Outcome measures

Measure	Arm I (Paclitaxel, Cisplatin) n=74 Participants Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Vinorelbine, Cisplatin) n=83 Participants Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Arm III (Gemcitabine, Cisplatin) n=86 Participants Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Arm IV (Topotecan, Cisplatin) n=92 Participants Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
Pain, Assessed by Brief Pain Inventory Pre-cycle 5	3.6 units on a scale Standard Deviation 3.1	4.0 units on a scale Standard Deviation 2.7	3.5 units on a scale Standard Deviation 3.0	2.5 units on a scale Standard Deviation 3.0
Pain, Assessed by Brief Pain Inventory Baseline	4.0 units on a scale Standard Deviation 2.8	3.9 units on a scale Standard Deviation 3.2	3.3 units on a scale Standard Deviation 3.0	3.6 units on a scale Standard Deviation 3.3
Pain, Assessed by Brief Pain Inventory Pre-cycle 2	3.5 units on a scale Standard Deviation 2.9	3.5 units on a scale Standard Deviation 2.8	3.4 units on a scale Standard Deviation 3.0	3.6 units on a scale Standard Deviation 3.1
Pain, Assessed by Brief Pain Inventory 9 months post cycle 1	2.3 units on a scale Standard Deviation 3.0	3.2 units on a scale Standard Deviation 2.9	3.7 units on a scale Standard Deviation 3.0	2.9 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

Population: Patients who provided baseline and ≥ one follow-up assessments

The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity.

Outcome measures

Measure	Arm I (Paclitaxel, Cisplatin) n=84 Participants Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Vinorelbine, Cisplatin) n=89 Participants Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Arm III (Gemcitabine, Cisplatin) n=91 Participants Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Arm IV (Topotecan, Cisplatin) n=96 Participants Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). Baseline	14.4 units on a scale Standard Deviation 2.9	13.5 units on a scale Standard Deviation 3.4	14.2 units on a scale Standard Deviation 2.9	14.1 units on a scale Standard Deviation 3.5
Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). Pre-cycle 2	14.1 units on a scale Standard Deviation 3.2	13.3 units on a scale Standard Deviation 3.6	13.7 units on a scale Standard Deviation 3.5	14.2 units on a scale Standard Deviation 3.2
Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). Pre-cycle 5	13.1 units on a scale Standard Deviation 3.5	13.1 units on a scale Standard Deviation 3.7	14.1 units on a scale Standard Deviation 3.0	14.4 units on a scale Standard Deviation 3.2
Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). 9 months post cycle 1	11.1 units on a scale Standard Deviation 5.2	11.4 units on a scale Standard Deviation 4.7	12.3 units on a scale Standard Deviation 3.7	13.1 units on a scale Standard Deviation 3.5

Adverse Events

Arm I (Paclitaxel, Cisplatin)

Serious events: 42 serious events

Other events: 101 other events

Deaths: 0 deaths

Arm II (Vinorelbine, Cisplatin)

Serious events: 39 serious events

Other events: 105 other events

Deaths: 0 deaths

Arm III (Gemcitabine, Cisplatin)

Serious events: 38 serious events

Other events: 109 other events

Deaths: 0 deaths

Arm IV (Topotecan, Cisplatin)

Serious events: 38 serious events

Other events: 108 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I (Paclitaxel, Cisplatin) n=103 participants at risk Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Vinorelbine, Cisplatin) n=108 participants at risk Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Arm III (Gemcitabine, Cisplatin) n=112 participants at risk Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Arm IV (Topotecan, Cisplatin) n=111 participants at risk Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
Blood and lymphatic system disorders Leukopenia	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.9% 2/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.8% 2/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Blood and lymphatic system disorders Anemia	2.9% 3/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.93% 1/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.8% 2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	2.7% 3/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Blood and lymphatic system disorders Thrombocytopenia	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Blood and lymphatic system disorders Neutropenia	2.9% 3/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	7.4% 8/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.8% 2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	6.3% 7/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Blood and lymphatic system disorders Transfusion Prbc's	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.93% 1/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Cardiac disorders Thrombosis Embolism	4.9% 5/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	8.3% 9/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	4.5% 5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	2.7% 3/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Cardiac disorders Ischemia/Cardiac Infarction	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.93% 1/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Cardiac disorders Sinus Tachycardia	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.93% 1/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Cardiac disorders Cardiac Left Ventricular Function	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Cardiac disorders Hypotension	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.9% 2/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Cardiac disorders Other Cardiovascular	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.8% 2/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Gastrointestinal disorders Nausea	1.9% 2/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Gastrointestinal disorders Vomiting	3.9% 4/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.93% 1/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Gastrointestinal disorders Diarrhea Without Colostomy	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.93% 1/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Gastrointestinal disorders Constipation	1.9% 2/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.8% 2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Gastrointestinal disorders Dehydration	4.9% 5/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.9% 2/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	2.7% 3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Gastrointestinal disorders Anorexia	1.9% 2/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Gastrointestinal disorders Ileus	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Gastrointestinal disorders Fistula Rectal/Anal	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.93% 1/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Gastrointestinal disorders Proctitis	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Gastrointestinal disorders Diarrhea With Colostomy	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Gastrointestinal disorders Fistula Intestinal	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Gastrointestinal disorders Gi Other	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
General disorders Fatigue	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
General disorders Fever(No Neutropenia)	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.9% 2/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.8% 2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
General disorders Bone Pain	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
General disorders Abdominal Pain	2.9% 3/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.9% 2/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	2.7% 3/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
General disorders Pain Rectal/Perirectal	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
General disorders Pain Other	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.9% 2/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Immune system disorders Allergic Reaction	1.9% 2/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Infections and infestations Febrile With Neutropenia	5.8% 6/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.9% 2/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.8% 2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.8% 2/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Infections and infestations Infection Without Neutropenia	6.8% 7/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	3.7% 4/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	3.6% 4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	4.5% 5/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Infections and infestations Infection With Grade 3/4 Neutropenia	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.9% 2/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	2.7% 3/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Infections and infestations Infection No Anc	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Infections and infestations Catheter-Related Infection	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Infections and infestations Infection Other	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.93% 1/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Infections and infestations Other Infection	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	2.8% 3/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Metabolism and nutrition disorders Hypokalemia	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Metabolism and nutrition disorders Acidosis	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.93% 1/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Metabolism and nutrition disorders Hyponatremia	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Metabolism and nutrition disorders Metabolic Other	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Musculoskeletal and connective tissue disorders Muscle Weakness	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Musculoskeletal and connective tissue disorders Musculoskeletal Other	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.93% 1/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Nervous system disorders Ataxia(Incoordination)	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Nervous system disorders Cns Cerebrovascular Ischemia	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Nervous system disorders Speech Impairment	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Renal and urinary disorders Creatinine	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.9% 2/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.8% 2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Renal and urinary disorders Renal Failure	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.9% 2/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Renal and urinary disorders Fistula	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.93% 1/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Renal and urinary disorders Ureteral Obstruction	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.9% 2/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	3.6% 4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	3.6% 4/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Renal and urinary disorders Renal/Gu Other	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Renal and urinary disorders Other Genitourinary/Renal	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.93% 1/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	2.7% 3/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Respiratory, thoracic and mediastinal disorders Pulmonary Other	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Skin and subcutaneous tissue disorders Wound Infectious	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Skin and subcutaneous tissue disorders Skin Other	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Vascular disorders Prothrombin Time	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Vascular disorders Hemorrhage With Grade 3/4 Thrombocytopenia	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Vascular disorders Melena/Gi Bleeding	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Vascular disorders Vaginal Bleeding	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.93% 1/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.8% 2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	2.7% 3/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Vascular disorders Hemoptysis	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Vascular disorders Rectal Bleeding/Hematochezia	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Vascular disorders Other Hemorrhage	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.

Other adverse events

Measure	Arm I (Paclitaxel, Cisplatin) n=103 participants at risk Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Vinorelbine, Cisplatin) n=108 participants at risk Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Arm III (Gemcitabine, Cisplatin) n=112 participants at risk Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Arm IV (Topotecan, Cisplatin) n=111 participants at risk Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
Blood and lymphatic system disorders Leukopenia	89.3% 92/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	90.7% 98/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	80.4% 90/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	91.9% 102/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Blood and lymphatic system disorders Anemia	91.3% 94/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	92.6% 100/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	92.9% 104/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	95.5% 106/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Blood and lymphatic system disorders Thrombocytopenia	35.0% 36/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	29.6% 32/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	78.6% 88/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	78.4% 87/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Blood and lymphatic system disorders Neutropenia	89.3% 92/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	87.0% 94/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	67.9% 76/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	91.9% 102/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Blood and lymphatic system disorders Otherhematologic	36.9% 38/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	49.1% 53/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	50.9% 57/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	51.4% 57/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Blood and lymphatic system disorders Lymphatics	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	2.8% 3/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.8% 2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	4.5% 5/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Cardiac disorders Thrombosis Embolism	4.9% 5/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	6.5% 7/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.8% 2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	4.5% 5/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Cardiac disorders Sinus Bradycardia	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Cardiac disorders Cardiac Left Ventricular Function	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.8% 2/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Cardiac disorders Other Cardiovascular	21.4% 22/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	13.9% 15/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	9.8% 11/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	11.7% 13/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Ear and labyrinth disorders Inner Ear/Hearing	9.7% 10/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	13.0% 14/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	15.2% 17/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	9.9% 11/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Ear and labyrinth disorders Other Hearing	1.9% 2/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.93% 1/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.8% 2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.8% 2/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Endocrine disorders Endocrine	8.7% 9/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	3.7% 4/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	3.6% 4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	4.5% 5/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Eye disorders Ocular	5.8% 6/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	4.6% 5/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	3.6% 4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	7.2% 8/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Gastrointestinal disorders Nausea	60.2% 62/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	59.3% 64/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	52.7% 59/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	55.0% 61/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Gastrointestinal disorders Vomiting	57.3% 59/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	47.2% 51/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	50.9% 57/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	44.1% 49/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Gastrointestinal disorders Stomatitis/Pharyngitis	17.5% 18/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	9.3% 10/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	18.8% 21/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	11.7% 13/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Gastrointestinal disorders Other Gastrointestinal	63.1% 65/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	62.0% 67/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	67.0% 75/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	59.5% 66/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
General disorders Fatigue	71.8% 74/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	75.9% 82/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	80.4% 90/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	76.6% 85/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
General disorders Other Constitutional	16.5% 17/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	21.3% 23/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	24.1% 27/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	25.2% 28/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
General disorders Myalgia	18.4% 19/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	8.3% 9/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	11.6% 13/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	10.8% 12/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
General disorders Other Pain	32.0% 33/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	43.5% 47/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	35.7% 40/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	36.0% 40/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Hepatobiliary disorders Hepatic	16.5% 17/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	12.0% 13/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	14.3% 16/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	18.0% 20/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Immune system disorders Allergic Reaction	9.7% 10/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	5.6% 6/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	3.6% 4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	8.1% 9/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Immune system disorders Other Allergy	0.97% 1/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	3.7% 4/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	2.7% 3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	2.7% 3/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Infections and infestations Febrile With Neutropenia	12.6% 13/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	13.9% 15/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	5.4% 6/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	9.9% 11/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Infections and infestations Infection Without Neutropenia	18.4% 19/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	11.1% 12/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	17.0% 19/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	8.1% 9/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Infections and infestations Other Infection	10.7% 11/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	11.1% 12/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	4.5% 5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	11.7% 13/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Metabolism and nutrition disorders Metabolic	48.5% 50/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	46.3% 50/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	43.8% 49/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	43.2% 48/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Musculoskeletal and connective tissue disorders Musculoskeletal	5.8% 6/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	5.6% 6/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	8.0% 9/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	7.2% 8/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Nervous system disorders Neuropathy Sensor	35.9% 37/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	30.6% 33/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	18.8% 21/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	20.7% 23/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Nervous system disorders Otherneurologic	26.2% 27/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	27.8% 30/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	25.0% 28/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	19.8% 22/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Renal and urinary disorders Creatinine	14.6% 15/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	16.7% 18/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	17.9% 20/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	14.4% 16/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Renal and urinary disorders Other Genitourinary/Renal	9.7% 10/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	8.3% 9/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	5.4% 6/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	12.6% 14/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Reproductive system and breast disorders Sexual/Reproductive	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.00% 0/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.8% 2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	1.8% 2/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Respiratory, thoracic and mediastinal disorders Pulmonary	19.4% 20/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	14.8% 16/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	9.8% 11/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	15.3% 17/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Skin and subcutaneous tissue disorders Alopecia	63.1% 65/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	24.1% 26/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	19.6% 22/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	43.2% 48/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Skin and subcutaneous tissue disorders Rash Desquamation	4.9% 5/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	2.8% 3/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	6.2% 7/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	6.3% 7/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Skin and subcutaneous tissue disorders Other Dermatologic	14.6% 15/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	13.0% 14/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	9.8% 11/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	6.3% 7/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Vascular disorders Coagulation	0.00% 0/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	2.8% 3/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.89% 1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	0.90% 1/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Vascular disorders Hemorrhage	5.8% 6/103 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	6.5% 7/108 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	8.9% 10/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.	8.1% 9/111 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.

Additional Information

Angela Kuras on behalf of Michael Sill and Helen Huang

NRG Oncology

Phone: 716-845-5702

Email: kurasa@nrgoncology.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60