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Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00942331
Recruitment Status : Active, not recruiting
First Posted : July 20, 2009
Results First Posted : February 17, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Advanced Urothelial Carcinoma
Metastatic Bladder Urothelial Carcinoma
Metastatic Prostate Carcinoma
Metastatic Renal Pelvis Urothelial Carcinoma
Metastatic Ureter Urothelial Carcinoma
Metastatic Urethral Urothelial Carcinoma
Metastatic Urothelial Carcinoma
Stage IV Bladder Urothelial Carcinoma AJCC v7
Stage IV Prostate Cancer AJCC v7
Stage IV Renal Pelvis Cancer AJCC v7
Stage IV Ureter Cancer AJCC v7
Stage IV Urethral Cancer AJCC v7
Unresectable Urothelial Carcinoma
Interventions Biological: Bevacizumab
Drug: Cisplatin
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Placebo Administration
Enrollment 506
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm II (GCB) Arm I (GCP)
Hide Arm/Group Description Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 252 254
Completed [1] 237 232
Not Completed 15 22
Reason Not Completed
Did not start treatment             15             22
[1]
Started treatment
Arm/Group Title Arm II (GCB) Arm I (GCP) Total
Hide Arm/Group Description Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 252 254 506
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 252 participants 254 participants 506 participants
64
(24 to 83)
63
(25 to 83)
63
(24 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 252 participants 254 participants 506 participants
Female
53
  21.0%
56
  22.0%
109
  21.5%
Male
199
  79.0%
198
  78.0%
397
  78.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 252 participants 254 participants 506 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   1.2%
4
   1.6%
7
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
13
   5.2%
5
   2.0%
18
   3.6%
White
229
  90.9%
235
  92.5%
464
  91.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
7
   2.8%
10
   3.9%
17
   3.4%
ECOG Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 252 participants 254 participants 506 participants
0
146
  57.9%
132
  52.0%
278
  54.9%
1
106
  42.1%
122
  48.0%
228
  45.1%
[1]
Measure Description: Eastern Cooperative Oncology Group PS Scale: 0)Fully active, able to carry on all pre-disease performance without restriction; 1)Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2)Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3)Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4)Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.The stratified log-rank statistic will be the primary analysis to compare the two treatment arms on OS with the stratification factors: presence of visceral metastases (no, yes) and prior chemotherapy (no, yes). In addition, the proportional hazards model will be used to assess the importance of the treatment arm adjusting on patient characteristics, stratification variables and other important covariates in predicting OS.
Time Frame From date of randomization to date of death due to any cause, assessed up to 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) analysis population
Arm/Group Title Arm II (GCB) Arm I (GCP)
Hide Arm/Group Description:
Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 252 254
Median (95% Confidence Interval)
Unit of Measure: months
14.5
(13.5 to 16.2)
14.3
(12.1 to 16.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm II (GCB), Arm I (GCP)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1707
Comments [Not Specified]
Method Log Rank
Comments Stratified log rank
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.72 to 1.06
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description The primary analysis of PFS will be a two-sided stratified log-rank test comparing arm A and arm B. The stratification factors will consist of the two stratification factors used for patient randomization: prior nephrectomy (yes vs. no) and Motzer score (0 vs. 1-2 vs. 3+). Results from unstratified log-rank tests will also be provided. Kaplan-Meier methodology will be used to estimate median PFS for each treatment arm.
Time Frame From the date of randomization to date of progression or death due to any cause, whichever occurs first, assessed up to 7 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Objective Response
Hide Description

Objective response is defined as confirmed complete and partial responses using Response Evaluation Criteria in Solid Tumors criteria. A complete response (CR) is defined as a disappearance of all target lesions. A partial response (PR) is defined as having at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum.

In each arm, the number of patients reporting a CR or PR was divided by the number of patients evaluable in each arm to obtain the proportion.

Time Frame Up to 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients registered, eligible and assessed for a response are included in this analysis.
Arm/Group Title Arm II (GCB) Arm I (GCP)
Hide Arm/Group Description:
Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 213 209
Measure Type: Number
Unit of Measure: proportion of participants
0.4 0.36
4.Secondary Outcome
Title Number of Patients Experiencing Grade 3+ Toxicity
Hide Description The number of patients experiencing grade 3 or higher toxicity (adverse events considered at least possibly related to treatment) is reported below.
Time Frame Up to 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who started treatment are evaluable for adverse events.
Arm/Group Title Arm II (GCB) Arm I (GCP)
Hide Arm/Group Description:
Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 237 232
Measure Type: Count of Participants
Unit of Measure: Participants
183
  77.2%
163
  70.3%
Time Frame Up to 7 years
Adverse Event Reporting Description All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
 
Arm/Group Title Arm II (GCB) Arm I (GCP)
Hide Arm/Group Description Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Arm II (GCB) Arm I (GCP)
Affected / at Risk (%) Affected / at Risk (%)
Total   207/252 (82.14%)      216/254 (85.04%)    
Hide Serious Adverse Events
Arm II (GCB) Arm I (GCP)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   95/237 (40.08%)      87/232 (37.50%)    
Blood and lymphatic system disorders     
Blood disorder  1  2/237 (0.84%)  2 1/232 (0.43%)  1
Febrile neutropenia  1  5/237 (2.11%)  5 5/232 (2.16%)  5
Hemoglobin decreased  1  72/237 (30.38%)  92 63/232 (27.16%)  78
Cardiac disorders     
Atrial fibrillation  1  2/237 (0.84%)  2 0/232 (0.00%)  0
Cardiac disorder  1  2/237 (0.84%)  3 0/232 (0.00%)  0
Cardiac pain  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Conduction disorder  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Left ventricular failure  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Myocardial ischemia  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Pericardial effusion  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Ventricular fibrillation  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Ear and labyrinth disorders     
Hearing impaired  1  0/237 (0.00%)  0 2/232 (0.86%)  2
Eye disorders     
Eye pain  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Gastrointestinal disorders     
Abdominal pain  1  3/237 (1.27%)  3 5/232 (2.16%)  5
Ascites  1  0/237 (0.00%)  0 2/232 (0.86%)  2
Colitis  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Colonic obstruction  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Colonic perforation  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Constipation  1  9/237 (3.80%)  9 3/232 (1.29%)  3
Diarrhea  1  2/237 (0.84%)  2 1/232 (0.43%)  1
Dry mouth  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Duodenal hemorrhage  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Duodenal obstruction  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Duodenal ulcer  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Gastric hemorrhage  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Gastrointestinal disorder  1  2/237 (0.84%)  2 0/232 (0.00%)  0
Ileus  1  2/237 (0.84%)  2 1/232 (0.43%)  1
Lower gastrointestinal hemorrhage  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Mucositis oral (clin exam)  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Mucositis oral (funct/sympt)  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Nausea  1  10/237 (4.22%)  10 8/232 (3.45%)  9
Oral hemorrhage  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Pancreatitis  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Small intestinal obstruction  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Upper gastrointestinal hemorrhage  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Vomiting  1  19/237 (8.02%)  20 29/232 (12.50%)  36
General disorders     
Chest pain  1  3/237 (1.27%)  3 1/232 (0.43%)  1
Chills  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Death NOS  1  0/237 (0.00%)  0 8/232 (3.45%)  8
Disease progression  1  2/237 (0.84%)  2 1/232 (0.43%)  1
Edema limbs  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Fatigue  1  71/237 (29.96%)  91 57/232 (24.57%)  77
Fever  1  2/237 (0.84%)  2 2/232 (0.86%)  2
General symptom  1  1/237 (0.42%)  2 1/232 (0.43%)  1
Ill-defined disorder  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Localized edema  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Pain  1  3/237 (1.27%)  4 0/232 (0.00%)  0
Sudden death  1  2/237 (0.84%)  2 1/232 (0.43%)  1
Hepatobiliary disorders     
Cholecystitis  1  2/237 (0.84%)  2 0/232 (0.00%)  0
Gallbladder obstruction  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Hepatic failure  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Infections and infestations     
Bladder infection(gr 3/4 ANC)  1  1/237 (0.42%)  1 3/232 (1.29%)  4
Bladder infection(unknown ANC)  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Catheter related infection  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Catheter related infection(gr 3/4 ANC)  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Gingival infection(unknown ANC)  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Infection(gr 0/1/2 ANC)  1  5/237 (2.11%)  6 6/232 (2.59%)  6
Kidney infection(gr 0/1/2 ANC)  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Kidney infection(gr 3/4 ANC)  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Opportunistic infection  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Phlebitis infective  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Pneumonia(gr 3/4 ANC)  1  2/237 (0.84%)  2 2/232 (0.86%)  4
Sepsis(gr 0/1/2 ANC)  1  1/237 (0.42%)  3 1/232 (0.43%)  1
Sepsis(unknown ANC)  1  2/237 (0.84%)  2 1/232 (0.43%)  1
Skin infection  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Skin infection(gr 3/4 ANC)  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Soft tissue infection(gr 0/1/2 ANC)  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Tooth infection(gr 3/4 ANC)  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Upper respiratory infectn(gr 0/1/2 ANC)  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Urinary tract infection(gr 0/1/2 ANC)  1  2/237 (0.84%)  2 2/232 (0.86%)  2
Urinary tract infection(gr 3/4 ANC)  1  4/237 (1.69%)  4 5/232 (2.16%)  6
Urinary tract infection(unknown ANC)  1  1/237 (0.42%)  1 2/232 (0.86%)  2
Injury, poisoning and procedural complications     
Fracture  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Intraoperative complications  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Postoperative hemorrhage  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Vascular access complication  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Investigations     
Activated partial throm time prolonged  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Alanine aminotransferase increased  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Alkaline phosphatase increased  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Aspartate aminotransferase increased  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Blood bilirubin increased  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Cardiac troponin I increased  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Creatinine increased  1  35/237 (14.77%)  40 39/232 (16.81%)  54
INR increased  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Leukocyte count decreased  1  6/237 (2.53%)  7 6/232 (2.59%)  8
Lymphocyte count decreased  1  6/237 (2.53%)  6 1/232 (0.43%)  1
Neutrophil count decreased  1  31/237 (13.08%)  39 29/232 (12.50%)  32
Platelet count decreased  1  50/237 (21.10%)  67 38/232 (16.38%)  46
Weight gain  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Metabolism and nutrition disorders     
Anorexia  1  4/237 (1.69%)  4 5/232 (2.16%)  6
Blood glucose increased  1  1/237 (0.42%)  1 3/232 (1.29%)  3
Dehydration  1  10/237 (4.22%)  10 8/232 (3.45%)  8
Obesity  1  2/237 (0.84%)  2 0/232 (0.00%)  0
Serum albumin decreased  1  1/237 (0.42%)  1 3/232 (1.29%)  4
Serum calcium decreased  1  2/237 (0.84%)  2 4/232 (1.72%)  5
Serum calcium increased  1  2/237 (0.84%)  2 0/232 (0.00%)  0
Serum glucose decreased  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Serum magnesium decreased  1  18/237 (7.59%)  19 20/232 (8.62%)  23
Serum phosphate decreased  1  3/237 (1.27%)  3 1/232 (0.43%)  1
Serum potassium decreased  1  13/237 (5.49%)  14 15/232 (6.47%)  18
Serum potassium increased  1  3/237 (1.27%)  3 4/232 (1.72%)  4
Serum sodium decreased  1  11/237 (4.64%)  12 8/232 (3.45%)  8
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/237 (0.84%)  2 0/232 (0.00%)  0
Back pain  1  3/237 (1.27%)  3 1/232 (0.43%)  1
Bone pain  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Buttock pain  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Chest wall pain  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Muscle weakness  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Musculoskeletal disorder  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Myalgia  1  2/237 (0.84%)  2 0/232 (0.00%)  0
Neck pain  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Pain in extremity  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Nervous system disorders     
Cognitive disturbance  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Dizziness  1  5/237 (2.11%)  5 2/232 (0.86%)  2
Dysgeusia  1  1/237 (0.42%)  1 1/232 (0.43%)  2
Encephalopathy  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Headache  1  2/237 (0.84%)  2 0/232 (0.00%)  0
Ischemia cerebrovascular  1  2/237 (0.84%)  2 2/232 (0.86%)  2
Leukoencephalopathy  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Neurological disorder NOS  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Peripheral motor neuropathy  1  2/237 (0.84%)  2 6/232 (2.59%)  6
Peripheral sensory neuropathy  1  14/237 (5.91%)  24 16/232 (6.90%)  20
Seizure  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Syncope  1  3/237 (1.27%)  3 3/232 (1.29%)  3
Psychiatric disorders     
Anxiety  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Confusion  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Depression  1  2/237 (0.84%)  2 0/232 (0.00%)  0
Psychosis  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Renal and urinary disorders     
Bladder hemorrhage  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Cystitis  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Glomerular filtration rate decreased  1  0/237 (0.00%)  0 1/232 (0.43%)  2
Hemorrhage urinary tract  1  7/237 (2.95%)  11 3/232 (1.29%)  4
Kidney pain  1  0/237 (0.00%)  0 2/232 (0.86%)  2
Kidney perforation  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Proteinuria  1  2/237 (0.84%)  2 0/232 (0.00%)  0
Renal failure  1  1/237 (0.42%)  1 5/232 (2.16%)  5
Ureteric obstruction  1  4/237 (1.69%)  4 3/232 (1.29%)  4
Ureteric perforation  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Urethral obstruction  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Urinary frequency  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Urinary incontinence  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Urine discoloration  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Urogenital disorder  1  2/237 (0.84%)  2 1/232 (0.43%)  1
Reproductive system and breast disorders     
Scrotal pain  1  2/237 (0.84%)  2 0/232 (0.00%)  0
Testicular pain  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Dyspnea  1  3/237 (1.27%)  3 6/232 (2.59%)  6
Epistaxis  1  13/237 (5.49%)  14 1/232 (0.43%)  1
Hiccups  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Hypoxia  1  2/237 (0.84%)  2 1/232 (0.43%)  1
Pleural effusion  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Respiratory disorder  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Rash desquamating  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Sweating  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Vascular disorders     
Hematoma  1  0/237 (0.00%)  0 2/232 (0.86%)  2
Hypertension  1  12/237 (5.06%)  14 1/232 (0.43%)  1
Hypotension  1  2/237 (0.84%)  2 1/232 (0.43%)  1
Lymphedema  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Thrombosis  1  6/237 (2.53%)  6 19/232 (8.19%)  24
Vascular disorder  1  0/237 (0.00%)  0 1/232 (0.43%)  1
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm II (GCB) Arm I (GCP)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   215/237 (90.72%)      205/232 (88.36%)    
Blood and lymphatic system disorders     
Blood disorder  1  0/237 (0.00%)  0 2/232 (0.86%)  2
Febrile neutropenia  1  4/237 (1.69%)  9 2/232 (0.86%)  2
Hemoglobin decreased  1  184/237 (77.64%)  1066 176/232 (75.86%)  1079
Hemolysis  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Lymphatic disorder  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Cardiac disorders     
Atrial tachycardia  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Myocardial ischemia  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Sinus tachycardia  1  2/237 (0.84%)  2 0/232 (0.00%)  0
Ear and labyrinth disorders     
Ear disorder  1  0/237 (0.00%)  0 2/232 (0.86%)  2
Ear pain  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Hearing impaired  1  0/237 (0.00%)  0 7/232 (3.02%)  55
Tinnitus  1  3/237 (1.27%)  9 5/232 (2.16%)  8
Endocrine disorders     
Adrenal insufficiency  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Eye disorders     
Vision blurred  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Gastrointestinal disorders     
Abdominal distension  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Abdominal pain  1  5/237 (2.11%)  12 4/232 (1.72%)  6
Anal fistula  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Anal hemorrhage  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Anal mucositis (clin exam)  1  1/237 (0.42%)  3 0/232 (0.00%)  0
Constipation  1  15/237 (6.33%)  34 16/232 (6.90%)  27
Dental prosthesis user  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Diarrhea  1  4/237 (1.69%)  4 5/232 (2.16%)  5
Dry mouth  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Dyspepsia  1  2/237 (0.84%)  7 3/232 (1.29%)  3
Dysphagia  1  2/237 (0.84%)  2 0/232 (0.00%)  0
Esophagitis  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Flatulence  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Gastric hemorrhage  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Gastritis  1  0/237 (0.00%)  0 2/232 (0.86%)  2
Gastrointestinal disorder  1  4/237 (1.69%)  8 4/232 (1.72%)  5
Hemorrhoids  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Ileus  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Mucositis oral (clin exam)  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Mucositis oral (funct/sympt)  1  2/237 (0.84%)  2 1/232 (0.43%)  1
Nausea  1  16/237 (6.75%)  27 25/232 (10.78%)  41
Periodontal disease  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Proctitis  1  1/237 (0.42%)  3 0/232 (0.00%)  0
Rectal pain  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Tooth disorder  1  1/237 (0.42%)  2 1/232 (0.43%)  1
Toothache  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Vomiting  1  62/237 (26.16%)  122 67/232 (28.88%)  175
General disorders     
Chest pain  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Chills  1  3/237 (1.27%)  3 1/232 (0.43%)  1
Edema limbs  1  4/237 (1.69%)  8 6/232 (2.59%)  14
Fatigue  1  192/237 (81.01%)  1119 180/232 (77.59%)  1076
Fever  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Flu-like symptoms  1  1/237 (0.42%)  1 0/232 (0.00%)  0
General symptom  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Localized edema  1  0/237 (0.00%)  0 2/232 (0.86%)  3
Pain  1  3/237 (1.27%)  4 8/232 (3.45%)  13
Immune system disorders     
Hypersensitivity  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Infections and infestations     
Anal infection(gr 0/1/2 ANC)  1  1/237 (0.42%)  3 0/232 (0.00%)  0
Anorectal infection(gr 0/1/2 ANC)  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Catheter related infection  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Catheter related infection(gr 0/1/2 ANC)  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Catheter related infection(gr 3/4 ANC)  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Infection(gr 0/1/2 ANC)  1  3/237 (1.27%)  3 1/232 (0.43%)  1
Kidney infection(gr 0/1/2 ANC)  1  1/237 (0.42%)  2 0/232 (0.00%)  0
Phlebitis infective  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Phlebitis infective(gr 3/4 ANC)  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Pneumonia(gr 3/4 ANC)  1  2/237 (0.84%)  2 0/232 (0.00%)  0
Sepsis(gr 3/4 ANC)  1  0/237 (0.00%)  0 1/232 (0.43%)  2
Sinusitis(gr 3/4 ANC)  1  1/237 (0.42%)  2 0/232 (0.00%)  0
Skin infection  1  2/237 (0.84%)  2 0/232 (0.00%)  0
Skin infection(gr 3/4 ANC)  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Upper respiratory infection(gr 3/4 ANC)  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Upper respiratory infectn(gr 0/1/2 ANC)  1  0/237 (0.00%)  0 2/232 (0.86%)  2
Urinary tract infection(gr 0/1/2 ANC)  1  1/237 (0.42%)  4 1/232 (0.43%)  1
Urinary tract infection(gr 3/4 ANC)  1  4/237 (1.69%)  7 1/232 (0.43%)  1
Urinary tract infection(unknown ANC)  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Injury, poisoning and procedural complications     
Bruising  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Fracture  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Vascular access complication  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Investigations     
Activated partial throm time prolonged  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Alanine aminotransferase increased  1  10/237 (4.22%)  20 3/232 (1.29%)  5
Alkaline phosphatase increased  1  5/237 (2.11%)  10 6/232 (2.59%)  11
Amylase increased  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Aspartate aminotransferase increased  1  5/237 (2.11%)  8 4/232 (1.72%)  6
Blood bilirubin increased  1  2/237 (0.84%)  7 0/232 (0.00%)  0
CD4 lymphocytes decreased  1  0/237 (0.00%)  0 1/232 (0.43%)  4
Creatinine increased  1  116/237 (48.95%)  630 102/232 (43.97%)  464
INR increased  1  4/237 (1.69%)  5 1/232 (0.43%)  2
Laboratory test abnormal  1  2/237 (0.84%)  2 3/232 (1.29%)  3
Leukocyte count decreased  1  23/237 (9.70%)  31 29/232 (12.50%)  53
Lymphocyte count decreased  1  10/237 (4.22%)  15 8/232 (3.45%)  15
Neutrophil count decreased  1  149/237 (62.87%)  397 130/232 (56.03%)  370
Platelet count decreased  1  140/237 (59.07%)  557 106/232 (45.69%)  331
Serum cholesterol increased  1  0/237 (0.00%)  0 1/232 (0.43%)  16
Weight gain  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Weight loss  1  5/237 (2.11%)  10 1/232 (0.43%)  1
Metabolism and nutrition disorders     
Anorexia  1  15/237 (6.33%)  22 6/232 (2.59%)  11
Blood bicarbonate decreased  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Blood glucose increased  1  14/237 (5.91%)  39 17/232 (7.33%)  33
Dehydration  1  6/237 (2.53%)  8 1/232 (0.43%)  1
Obesity  1  1/237 (0.42%)  1 1/232 (0.43%)  7
Serum albumin decreased  1  1/237 (0.42%)  2 3/232 (1.29%)  7
Serum calcium decreased  1  4/237 (1.69%)  4 3/232 (1.29%)  7
Serum glucose decreased  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Serum magnesium decreased  1  49/237 (20.68%)  135 44/232 (18.97%)  129
Serum magnesium increased  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Serum potassium decreased  1  38/237 (16.03%)  60 40/232 (17.24%)  62
Serum potassium increased  1  8/237 (3.38%)  10 3/232 (1.29%)  3
Serum sodium decreased  1  17/237 (7.17%)  27 8/232 (3.45%)  13
Serum sodium increased  1  1/237 (0.42%)  4 0/232 (0.00%)  0
Serum triglycerides increased  1  0/237 (0.00%)  0 1/232 (0.43%)  5
Musculoskeletal and connective tissue disorders     
Arthralgia  1  5/237 (2.11%)  6 4/232 (1.72%)  5
Arthritis  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Back pain  1  9/237 (3.80%)  15 10/232 (4.31%)  17
Bone pain  1  4/237 (1.69%)  4 2/232 (0.86%)  3
Muscle weakness  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Musculoskeletal disorder  1  2/237 (0.84%)  3 2/232 (0.86%)  3
Myalgia  1  3/237 (1.27%)  4 2/232 (0.86%)  2
Neck pain  1  1/237 (0.42%)  2 1/232 (0.43%)  1
Pain in extremity  1  2/237 (0.84%)  2 4/232 (1.72%)  8
Upper extremity dysfunction  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Myelodysplasia  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Tumor pain  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Nervous system disorders     
Acoustic nerve disorder NOS  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Dizziness  1  2/237 (0.84%)  2 4/232 (1.72%)  5
Dysgeusia  1  2/237 (0.84%)  2 2/232 (0.86%)  3
Headache  1  12/237 (5.06%)  24 2/232 (0.86%)  2
Neurological disorder NOS  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Peripheral motor neuropathy  1  18/237 (7.59%)  35 20/232 (8.62%)  96
Peripheral sensory neuropathy  1  85/237 (35.86%)  533 87/232 (37.50%)  549
Syncope  1  3/237 (1.27%)  3 1/232 (0.43%)  1
Tremor  1  1/237 (0.42%)  2 1/232 (0.43%)  1
Psychiatric disorders     
Anxiety  1  2/237 (0.84%)  7 4/232 (1.72%)  13
Depression  1  3/237 (1.27%)  10 2/232 (0.86%)  4
Insomnia  1  5/237 (2.11%)  6 3/232 (1.29%)  3
Renal and urinary disorders     
Bladder pain  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Bladder spasm  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Cystitis  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Glomerular filtration rate decreased  1  2/237 (0.84%)  5 2/232 (0.86%)  2
Hemorrhage urinary tract  1  44/237 (18.57%)  155 44/232 (18.97%)  176
Proteinuria  1  21/237 (8.86%)  49 7/232 (3.02%)  12
Renal failure  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Renal hemorrhage  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Ureteric hemorrhage  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Urethral pain  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Urinary frequency  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Urinary incontinence  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Urinary retention  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Urogenital disorder  1  0/237 (0.00%)  0 3/232 (1.29%)  7
Reproductive system and breast disorders     
Erectile dysfunction  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Pelvic pain  1  0/237 (0.00%)  0 1/232 (0.43%)  2
Scrotal pain  1  1/237 (0.42%)  7 0/232 (0.00%)  0
Vaginal pain  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  1/237 (0.42%)  5 0/232 (0.00%)  0
Cough  1  4/237 (1.69%)  9 2/232 (0.86%)  2
Dyspnea  1  5/237 (2.11%)  13 4/232 (1.72%)  7
Epistaxis  1  70/237 (29.54%)  220 15/232 (6.47%)  23
Hiccups  1  2/237 (0.84%)  2 0/232 (0.00%)  0
Hypoxia  1  1/237 (0.42%)  1 1/232 (0.43%)  1
Laryngeal pain  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Pleuritic pain  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Pulmonary hemorrhage  1  6/237 (2.53%)  16 2/232 (0.86%)  2
Respiratory disorder  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Sinus pain  1  2/237 (0.84%)  3 0/232 (0.00%)  0
Voice alteration  1  3/237 (1.27%)  11 0/232 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  6/237 (2.53%)  17 3/232 (1.29%)  9
Dry skin  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Pruritus  1  3/237 (1.27%)  3 0/232 (0.00%)  0
Rash acneiform  1  2/237 (0.84%)  2 0/232 (0.00%)  0
Rash desquamating  1  5/237 (2.11%)  8 3/232 (1.29%)  3
Scalp pain  1  1/237 (0.42%)  1 0/232 (0.00%)  0
Skin hyperpigmentation  1  2/237 (0.84%)  3 0/232 (0.00%)  0
Vascular disorders     
Hypertension  1  50/237 (21.10%)  175 15/232 (6.47%)  29
Lymphedema  1  0/237 (0.00%)  0 1/232 (0.43%)  1
Peripheral ischemia  1  0/237 (0.00%)  0 1/232 (0.43%)  6
Phlebitis  1  2/237 (0.84%)  2 2/232 (0.86%)  2
Thrombosis  1  24/237 (10.13%)  63 19/232 (8.19%)  32
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jonathan Rosenberg, MD
Organization: Memorial Sloan-Kettering Cancer Center
Phone: 646-422-4461
EMail: rosenbj1@mskcc.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00942331    
Other Study ID Numbers: NCI-2011-01952
NCI-2011-01952 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000649174
CALGB-90601 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-90601 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: July 17, 2009
First Posted: July 20, 2009
Results First Submitted: January 30, 2020
Results First Posted: February 17, 2020
Last Update Posted: November 9, 2020