Trial Outcomes & Findings for MV-NIS or Investigator's Choice Chemotherapy in Treating Patients With Ovarian, Fallopian, or Peritoneal Cancer (NCT NCT02364713)

Last Updated: 2025-12-11

Results Overview

Defined as the time from registration/randomization to death due to all causes. Will be a comparison of the oncolytic measles virus encoding thyroidal sodium iodide symporter versus investigator's choice chemotherapy using a one-sided log-rank test.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

5 years

Results posted on

2025-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A (MV-NIS) Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter: Given IP\> \> Quality-of-Life Assessment: Ancillary studies	Arm B (DOXIL, GEM, TOPA, TAXOL) Patients receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15, or paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may also receive bevacizumab IV over 30-90 minutes on days 1 and 15 with pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, or paclitaxel. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Bevacizumab: Given IV\> \> Gemcitabine Hydrochloride: Given IV\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Paclitaxel: Given IV\> \> Pegylated Liposomal Doxorubicin Hydrochloride: Given IV\> \> Quality-of-Life Assessment: Ancillary studies\> \> Topotecan Hydrochloride: Given IV
Overall Study STARTED	10	7
Overall Study COMPLETED	8	5
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A (MV-NIS) Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter: Given IP\> \> Quality-of-Life Assessment: Ancillary studies	Arm B (DOXIL, GEM, TOPA, TAXOL) Patients receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15, or paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may also receive bevacizumab IV over 30-90 minutes on days 1 and 15 with pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, or paclitaxel. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Bevacizumab: Given IV\> \> Gemcitabine Hydrochloride: Given IV\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Paclitaxel: Given IV\> \> Pegylated Liposomal Doxorubicin Hydrochloride: Given IV\> \> Quality-of-Life Assessment: Ancillary studies\> \> Topotecan Hydrochloride: Given IV
Overall Study Ineligible	2	2

Baseline Characteristics

MV-NIS or Investigator's Choice Chemotherapy in Treating Patients With Ovarian, Fallopian, or Peritoneal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (MV-NIS) n=10 Participants Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter: Given IP\> \> Quality-of-Life Assessment: Ancillary studies	Arm B (DOXIL, GEM, TOPA, TAXOL) n=7 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15, or paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may also receive bevacizumab IV over 30-90 minutes on days 1 and 15 with pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, or paclitaxel. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Bevacizumab: Given IV\> \> Gemcitabine Hydrochloride: Given IV\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Paclitaxel: Given IV\> \> Pegylated Liposomal Doxorubicin Hydrochloride: Given IV\> \> Quality-of-Life Assessment: Ancillary studies\> \> Topotecan Hydrochloride: Given IV	Total n=17 Participants Total of all reporting groups
Age, Continuous	68 years n=237 Participants	64 years n=243 Participants	67 years n=480 Participants
Sex: Female, Male Female	10 Participants n=237 Participants	7 Participants n=243 Participants	17 Participants n=480 Participants
Sex: Female, Male Male	0 Participants n=237 Participants	0 Participants n=243 Participants	0 Participants n=480 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=237 Participants	1 Participants n=243 Participants	3 Participants n=480 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=237 Participants	5 Participants n=243 Participants	13 Participants n=480 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=237 Participants	1 Participants n=243 Participants	1 Participants n=480 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=237 Participants	0 Participants n=243 Participants	0 Participants n=480 Participants
Race (NIH/OMB) Asian	0 Participants n=237 Participants	0 Participants n=243 Participants	0 Participants n=480 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=237 Participants	0 Participants n=243 Participants	0 Participants n=480 Participants
Race (NIH/OMB) Black or African American	0 Participants n=237 Participants	0 Participants n=243 Participants	0 Participants n=480 Participants
Race (NIH/OMB) White	10 Participants n=237 Participants	6 Participants n=243 Participants	16 Participants n=480 Participants
Race (NIH/OMB) More than one race	0 Participants n=237 Participants	0 Participants n=243 Participants	0 Participants n=480 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=237 Participants	1 Participants n=243 Participants	1 Participants n=480 Participants

PRIMARY outcome

Timeframe: 5 years

Population: All eligible and treated patients

Outcome measures

Outcome measures
Measure	Arm A (MV-NIS) n=8 Participants Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (DOXIL, GEM, TOPA, TAXOL) n=5 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15, or paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may also receive bevacizumab IV over 30-90 minutes on days 1 and 15 with pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, or paclitaxel. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Survival	11.2 Months Interval 3.5 to Too few events to calculate the upper limit	14.2 Months Interval 10.6 to Too few events to calculate the upper limit

SECONDARY outcome

Timeframe: 11 months

Population: All eligible and treated patients

Defined as the time from start of study therapy to the date of first observation of disease progression or death due to any cause (whichever comes first). The distribution of progression-free survival for both arms of the study will be estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Arm A (MV-NIS) n=8 Participants Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (DOXIL, GEM, TOPA, TAXOL) n=5 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15, or paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may also receive bevacizumab IV over 30-90 minutes on days 1 and 15 with pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, or paclitaxel. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Progression-free Survival	1.8 Months Interval 1.7 to Too few events to calculate the upper limit	4.1 Months Interval 1.8 to Too few events to calculate the upper limit

SECONDARY outcome

Timeframe: 12 months

Population: All eligible and treated patients

Defined as the time from registration/randomization to death due to all causes. Overall survival at 12 months distributions both arms of the study will be estimated using the Kaplan-Meier method and be compared using a one-sided logrank test.

Outcome measures

Outcome measures
Measure	Arm A (MV-NIS) n=8 Participants Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (DOXIL, GEM, TOPA, TAXOL) n=5 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15, or paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may also receive bevacizumab IV over 30-90 minutes on days 1 and 15 with pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, or paclitaxel. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Survival	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months

Progression-free survival at 6 months distributions both arms of the study will be estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Arm A (MV-NIS) n=8 Participants Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (DOXIL, GEM, TOPA, TAXOL) n=5 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15, or paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may also receive bevacizumab IV over 30-90 minutes on days 1 and 15 with pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, or paclitaxel. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Progression-free Survival	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 11 months

Objective response rate is defined to be a complete response or partial response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart

Outcome measures

Outcome measures
Measure	Arm A (MV-NIS) n=8 Participants Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (DOXIL, GEM, TOPA, TAXOL) n=5 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15, or paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may also receive bevacizumab IV over 30-90 minutes on days 1 and 15 with pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, or paclitaxel. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Objective Response Rate	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Safety and tolerability of the oncolytic measles virus encoding thyroidal sodium iodide symporter as compared to standard therapy will be evaluated using all patients who have received any study treatment as well as summarizing those who have been included in the efficacy analyses. The overall adverse event rates for grade 3 or higher adverse events will be compared between arms.

Outcome measures

Outcome measures
Measure	Arm A (MV-NIS) n=8 Participants Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (DOXIL, GEM, TOPA, TAXOL) n=5 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15, or paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may also receive bevacizumab IV over 30-90 minutes on days 1 and 15 with pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, or paclitaxel. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 5 years

Quality of life as measured by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire will be compared between treatment arms. The assessment will be scored according to the assessment scoring algorithm at each collection time. Scores at end of each cycle will be compared using Wilcoxon procedures. The FACT-O consist of 39 questions, each answered on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Possible total scores range from 0-156, with higher scores indicating better quality of life. We will calculate the mean change from the start to the end of the study of patient total FACT-O point sum by arm.

Outcome measures

Outcome measures
Measure	Arm A (MV-NIS) n=6 Participants Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (DOXIL, GEM, TOPA, TAXOL) n=3 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15, or paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may also receive bevacizumab IV over 30-90 minutes on days 1 and 15 with pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, or paclitaxel. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Ovarian Questionnaire	5.2 change in score Standard Deviation 14.6	-12.6 change in score Standard Deviation 12.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to course 2

Descriptive statistics and simple scatter plots will form the basis of presentation of these data. Correlations between these laboratory values and other outcome measures will be carried out by standard parametric and nonparametric correlation procedures (Pearson's and Spearman's coefficients).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to up to 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

Adverse Events

Arm A (MV-NIS)

Serious events: 6 serious events

Other events: 8 other events

Deaths: 8 deaths

Arm B (DOXIL, GEM, TOPA, TAXOL)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Evanthia Galanis

Mayo Clinic

Phone: 507-266-0584

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A (MV-NIS) n=9 participants at risk Quality-of-Life Assessment: Ancillary studies	Arm B (DOXIL, GEM, TOPA, TAXOL) n=5 participants at risk Topotecan Hydrochloride: Given IV
Gastrointestinal disorders Nausea	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Gastrointestinal disorders Obstruction gastric	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Gastrointestinal disorders Small intestinal obstruction	22.2% 2/9 • Number of events 2 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Gastrointestinal disorders Small intestinal perforation	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Gastrointestinal disorders Vomiting	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Infections and infestations Nail infection	0.00% 0/9 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	20.0% 1/5 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Infections and infestations Sepsis	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Investigations Alanine aminotransferase increased	0.00% 0/9 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	20.0% 1/5 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Investigations Alkaline phosphatase increased	0.00% 0/9 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	20.0% 1/5 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Investigations Aspartate aminotransferase increased	0.00% 0/9 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	20.0% 1/5 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Renal and urinary disorders Acute kidney injury	0.00% 0/9 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	20.0% 1/5 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Cardiac disorders Atrial fibrillation	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/9 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	20.0% 1/5 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Skin and subcutaneous tissue disorders Rash maculo-papular	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.

Measure	Arm A (MV-NIS) n=9 participants at risk Quality-of-Life Assessment: Ancillary studies	Arm B (DOXIL, GEM, TOPA, TAXOL) n=5 participants at risk Topotecan Hydrochloride: Given IV
Gastrointestinal disorders Flatulence	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Gastrointestinal disorders Nausea	33.3% 3/9 • Number of events 4 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	20.0% 1/5 • Number of events 2 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Gastrointestinal disorders Vomiting	55.6% 5/9 • Number of events 7 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	20.0% 1/5 • Number of events 2 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
General disorders Chills	11.1% 1/9 • Number of events 2 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
General disorders Fatigue	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
General disorders Fever	33.3% 3/9 • Number of events 6 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Investigations Investigations - Other, specify	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Investigations Lymphocyte count decreased	11.1% 1/9 • Number of events 2 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Investigations Neutrophil count decreased	0.00% 0/9 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	20.0% 1/5 • Number of events 5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Investigations Platelet count decreased	11.1% 1/9 • Number of events 5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Investigations White blood cell decreased	0.00% 0/9 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	60.0% 3/5 • Number of events 9 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Metabolism and nutrition disorders Hypermagnesemia	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Metabolism and nutrition disorders Hypoalbuminemia	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Metabolism and nutrition disorders Hypocalcemia	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Metabolism and nutrition disorders Hypokalemia	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Metabolism and nutrition disorders Hyponatremia	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Metabolism and nutrition disorders Obesity	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Nervous system disorders Encephalopathy	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Nervous system disorders Peripheral motor neuropathy	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	20.0% 1/5 • Number of events 2 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Nervous system disorders Peripheral sensory neuropathy	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	20.0% 1/5 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/9 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	20.0% 1/5 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrm	0.00% 0/9 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	20.0% 1/5 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Skin and subcutaneous tissue disorders Rash maculo-papular	22.2% 2/9 • Number of events 4 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	20.0% 1/5 • Number of events 2 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Skin and subcutaneous tissue disorders Skin and subcut tissue disord - Oth spec	0.00% 0/9 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	20.0% 1/5 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Vascular disorders Hypertension	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Blood and lymphatic system disorders Anemia	22.2% 2/9 • Number of events 2 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Endocrine disorders Hypothyroidism	11.1% 1/9 • Number of events 1 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Number of events 2 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.
Gastrointestinal disorders Diarrhea	33.3% 3/9 • Number of events 6 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.	0.00% 0/5 • Adverse events were followed for 12 months and mortality was followed for 5 years All accrued patients are included in mortality reporting. All treated patients are included in the adverse events, this includes a patient that's been deemed ineligible.