Trial Outcomes & Findings for S0028, Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract (NCT NCT00022633)

Last Updated: 2016-08-11

Results Overview

Sixty patients aged 70 years and older were to be accrued to the study. The feasibility of accrual was determined that accrual of 3 patients per month in the age 70 and older range would allow for an expeditiously conducted phase II trial. If, after a 3 month start-up period, 3 or more patients aged 70 years and older were accrued per month for the duration of the trial, it was deemed reasonable to consider further trials in this elderly population.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

65 participants

Primary outcome timeframe

66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)

Results posted on

2016-08-11

Participant Flow

The purpose of the subset of patients who aged 60 years or younger was to serve as a younger reference group for the pharmacokinetic parameter estimation. Therefore, this younger cohort is not included in analyses of adverse event, efficacy, and feasibility assessment of patient-reported outcome measures.

Participant milestones

Participant milestones
Measure	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)	Paclitaxel + Gemcitabine (Younger Cohort: Age < 60) Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Overall Study STARTED	55	10
Overall Study Eligible	51	10
Overall Study COMPLETED	23	5
Overall Study NOT COMPLETED	32	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)	Paclitaxel + Gemcitabine (Younger Cohort: Age < 60) Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Overall Study Adverse Event	11	1
Overall Study Refusal unrelated to adverse event	1	0
Overall Study Progression/relapse	9	2
Overall Study Death	4	0
Overall Study Other - not protocol specified	3	2
Overall Study Ineligible	4	0

Baseline Characteristics

S0028, Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) n=51 Participants Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)	Paclitaxel + Gemcitabine (Younger Cohort: Age < 60) n=10 Participants Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)	Total n=61 Participants Total of all reporting groups
Age, Continuous	76.1 years n=5 Participants	53.8 years n=7 Participants	74.6 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	4 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	6 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants	9 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants	7 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)

Population: A total of 55 patients aged 70 years and older were registered to this protocol from July, 2001 to December, 2006.

Outcome measures

Outcome measures
Measure	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) n=55 Participants Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols	55 participants

SECONDARY outcome

Timeframe: every week for the first 4 weeks and then every 3 weeks for up to 19 weeks

Population: Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.

Complete response (CR) is defined as complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial response (PR) applies only to patients with least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.

Outcome measures

Outcome measures
Measure	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) n=51 Participants Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)	22 percentage of participants Interval 11.0 to 35.0

SECONDARY outcome

Timeframe: 0-5 years

Measured form date of registration to date of first observation of progression disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment.

Outcome measures

Outcome measures
Measure	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) n=51 Participants Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Progression-free Survival in Patients Aged 70 Years and Older	6 months Interval 4.0 to 7.0

SECONDARY outcome

Timeframe: 0-5 years

Measured from date of registration to date of death due to any cause.

Outcome measures

Outcome measures
Measure	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) n=51 Participants Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Overall Survival (OS) in Patients Aged 70 Years and Older	11 months Interval 8.0 to 13.0

SECONDARY outcome

Timeframe: Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment.

Population: Eligible patients aged 70 years and older who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3, Grade 4, or Grade 5 which deemed to be related to protocol treatment are included. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study are excluded

Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Outcome measures

Outcome measures
Measure	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) n=51 Participants Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Cardiac ischemia/infarction	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Chest pain,not cardio or pleur	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Abdominal pain/cramping	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Acidosis	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Allergic reaction	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Anemia	6 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Anorexia	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Bone pain	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Confusion	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Constipation/bowel obstruction	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Creatinine increase	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Dehydration	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Diarrhea without colostomy	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Dizziness/light headedness	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Dyspepsia/heartburn	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Dyspnea	6 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Edema	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Fatigue/malaise/lethargy	8 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Febrile neutropenia	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Gastric ulcer	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hyperglycemia	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hyperkalemia	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hypotension	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Infection w/o 3-4 neutropenia	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Infection with 3-4 neutropenia	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Infection, unk ANC	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Leukopenia	6 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Muscle weakness (not neuro)	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Myalgia/arthralgia, NOS	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Nausea	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Neuropathic pain	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Neutropenia/granulocytopenia	26 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug PRBC transfusion	10 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain-other	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pleural effusions	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pneumonitis/infiltrates	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Renal failure	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Respiratory infect w/ neutrop	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug SGOT (AST) increase	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Sensory neuropathy	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Supraventricular arrhythmia	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Thrombocytopenia	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Thrombosis/embolism	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Urinary tr infect w/ neutrop	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Urinary tr infect w/o neutrop	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Ventricular arrhythmia	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Vomiting	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Weakness (motor neuropathy)	2 Participants

SECONDARY outcome

Timeframe: at study entry (prior to administration of any treatment)

Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for each of three patient self-administered questionnaires (\> 60%); 2) the number of items missing within each scale (\< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.

Outcome measures

Outcome measures
Measure	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) n=51 Participants Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate Medical Conditions Questionnaire	98 percentage of participants
Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate Instrumental Activities of Daily Living Form	98 percentage of participants
Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate Feelings Questionnaire	98 percentage of participants

SECONDARY outcome

Timeframe: at study entry (prior to administration of any treatment)

Population: Eligible patients aged 70 years and older who had received any treatment were included in the analysis. One non-compliant patient who did not complete any of the forms was excluded. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.

Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the each of three patient self-administered questionnaires (\> 60%); 2) the number of items missing within each scale (\< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.

Outcome measures

Outcome measures
Measure	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) n=50 Participants Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms Medical Conditions Questionnaire	5 minutes Interval 1.0 to 45.0
Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms Instrumental Activities of Daily Living Form	3 minutes Interval 1.0 to 45.0
Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms Feelings Questionnaire	2 minutes Interval 1.0 to 30.0

SECONDARY outcome

Timeframe: at study entry (prior to administration of any treatment)

Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the three patient self-administered questionnaires (\> 60%); 2) the number of items missing within each scale (\< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.

Outcome measures

Outcome measures
Measure	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) n=50 Participants Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required Medical Conditions Questionnaire	28 percentage of participants
Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required Instrumental Activities of Daily Living Form	42 percentage of participants
Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required Feelings Questionnaire	34 percentage of participants

Adverse Events

Paclitaxel + Gemcitabine

Serious events: 5 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Paclitaxel + Gemcitabine n=51 participants at risk Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Cardiac disorders Cardiovascular-other	2.0% 1/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Cardiac disorders Supraventricular arrhythmia	2.0% 1/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Gastrointestinal disorders Ileus	2.0% 1/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
General disorders Flu-like symptoms-other	2.0% 1/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
General disorders Reportable adverse event, NOS	3.9% 2/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Infections and infestations Respiratory infect w/ neutrop	2.0% 1/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Metabolism and nutrition disorders Acidosis	2.0% 1/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Metabolism and nutrition disorders Dehydration	2.0% 1/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Respiratory, thoracic and mediastinal disorders Dyspnea	2.0% 1/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)

Other adverse events

Other adverse events
Measure	Paclitaxel + Gemcitabine n=51 participants at risk Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Blood and lymphatic system disorders Anemia	56.9% 29/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Blood and lymphatic system disorders PRBC transfusion	19.6% 10/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Eye disorders Blurred vision	7.8% 4/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Gastrointestinal disorders Abdominal pain/cramping	11.8% 6/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Gastrointestinal disorders Constipation/bowel obstruction	31.4% 16/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Gastrointestinal disorders Diarrhea without colostomy	23.5% 12/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Gastrointestinal disorders Esophagitis/dysphagia	5.9% 3/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Gastrointestinal disorders Nausea	49.0% 25/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Gastrointestinal disorders Stomatitis/pharyngitis	7.8% 4/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Gastrointestinal disorders Vomiting	17.6% 9/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
General disorders Edema	27.5% 14/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
General disorders Fatigue/malaise/lethargy	82.4% 42/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
General disorders Fever without neutropenia	15.7% 8/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
General disorders Pain-other	15.7% 8/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
General disorders Rigors/chills	11.8% 6/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
General disorders Sweating	7.8% 4/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Immune system disorders Allergic reaction	5.9% 3/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Infections and infestations Infection with 3-4 neutropenia	5.9% 3/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Infections and infestations Urinary tr infect w/o neutrop	7.8% 4/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Investigations Alkaline phosphatase increase	15.7% 8/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Investigations Creatinine increase	13.7% 7/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Investigations Leukopenia	23.5% 12/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Investigations Neutropenia/granulocytopenia	70.6% 36/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Investigations SGOT (AST) increase	21.6% 11/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Investigations SGPT (ALT) increase	7.8% 4/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Investigations Thrombocytopenia	39.2% 20/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Investigations Weight loss	11.8% 6/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Metabolism and nutrition disorders Anorexia	45.1% 23/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Metabolism and nutrition disorders Hyperglycemia	13.7% 7/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Metabolism and nutrition disorders Hyperkalemia	5.9% 3/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Metabolism and nutrition disorders Hypoalbuminemia	7.8% 4/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Metabolism and nutrition disorders Hypocalcemia	5.9% 3/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Musculoskeletal and connective tissue disorders Arthralgia	17.6% 9/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Musculoskeletal and connective tissue disorders Bone pain	5.9% 3/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Musculoskeletal and connective tissue disorders Myalgia	39.2% 20/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Nervous system disorders Dizziness/light headedness	15.7% 8/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Nervous system disorders Headache	9.8% 5/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Nervous system disorders Neuropathic pain	7.8% 4/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Nervous system disorders Sensory neuropathy	41.2% 21/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Nervous system disorders Taste disturbance	7.8% 4/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Nervous system disorders Weakness (motor neuropathy)	9.8% 5/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Psychiatric disorders Confusion	7.8% 4/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Psychiatric disorders Insomnia	23.5% 12/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Renal and urinary disorders Urinary frequency/urgency	5.9% 3/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Respiratory, thoracic and mediastinal disorders Cough	17.6% 9/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 17/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Respiratory, thoracic and mediastinal disorders Hiccoughs	5.9% 3/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Skin and subcutaneous tissue disorders Alopecia	52.9% 27/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Skin and subcutaneous tissue disorders Rash/desquamation	7.8% 4/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)
Vascular disorders Hypotension	5.9% 3/51 • Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. Elderly Cohort (Age \>= 70 years)

Additional Information

Dr. Derek Raghavan

Cleveland Clinic

Phone: 216-445-6888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place