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

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ClinicalTrials.gov Identifier: NCT00942331

Recruitment Status : Completed

First Posted : July 20, 2009

Results First Posted : February 17, 2020

Last Update Posted : October 16, 2023

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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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Arm II (GCB)	Arm I (GCP)
Arm/Group Description	Patients receive gemcitabine hydroc...	Patients receive gemcitabine hydroc...
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

Baseline Characteristics

Arm/Group Title		Arm II (GCB)	Arm I (GCP)	Total
Arm/Group Description		Patients receive gemcitabine hydroc...	Patients receive gemcitabine hydroc...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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.

Outcome Measures

1.Primary Outcome


Title	Overall Survival (OS)
Description	Overall survival time is defined as the time from randomization to dea...
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

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) analysis population


Arm/Group Title	Arm II (GCB)	Arm I (GCP)
Arm/Group Description:	Patients receive gemcitabine hydroc...	Patients receive gemcitabine hydroc...
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)

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)
Description	The primary analysis of PFS will be a two-sided stratified log-rank te...
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

Analysis Population Description

[Not Specified]


Arm/Group Title	Arm II (GCB)	Arm I (GCP)
Arm/Group Description:	Patients receive gemcitabine hydroc...	Patients receive gemcitabine hydroc...
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
	8.0 (7.1 to 8.5)	6.7 (6.3 to 7.4)

3.Secondary Outcome


Title	Objective Response
Description	Objective response is defined as confirmed complete and partial respon...
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

Outcome Measure Data

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)
Arm/Group Description:	Patients receive gemcitabine hydroc...	Patients receive gemcitabine hydroc...
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
Description	The number of patients experiencing grade 3 or higher toxicity (advers...
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

Outcome Measure Data

Analysis Population Description

Patients who started treatment are evaluable for adverse events.


Arm/Group Title	Arm II (GCB)	Arm I (GCP)
Arm/Group Description:	Patients receive gemcitabine hydroc...	Patients receive gemcitabine hydroc...
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%

Adverse Events

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)
Arm/Group Description	Patients receive gemcitabine hydroc...		Patients receive gemcitabine hydroc...
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%)
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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

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Name/Title:	Jonathan Rosenberg, MD
Organization:	Memorial Sloan-Kettering Cancer Center
Phone:	646-422-4461
EMail:	rosenbj1@mskcc.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rosenberg JE, Ballman KA, Halabi S, Atherton PJ, Mortazavi A, Sweeney C, Stadler WM, Teply BA, Picus J, Tagawa ST, Katragadda S, Vaena D, Misleh J, Hoimes C, Plimack ER, Flaig TW, Dreicer R, Bajorin D, Hahn O, Small EJ, Morris MJ. Randomized Phase III Trial of Gemcitabine and Cisplatin With Bevacizumab or Placebo in Patients With Advanced Urothelial Carcinoma: Results of CALGB 90601 (Alliance). J Clin Oncol. 2021 Aug 1;39(22):2486-2496. doi: 10.1200/JCO.21.00286. Epub 2021 May 14.

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:	October 16, 2023

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