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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Cisplatin — DRUG
  Given IV
• Gemcitabine Hydrochloride — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Placebo Administration — OTHER
  Given IV

Study Details

This randomized phase III trial studies gemcitabine hydrochloride, cisplatin, and bevacizumab to see how well they work compared with gemcitabine hydrochloride and cisplatin in treating patients with urinary tract cancer that has spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with bevacizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether gemcitabine hydrochloride and cisplatin are more effective when given with or without bevacizumab in treating patients with urinary tract cancer.

Key Dates

First listed

Jul 20, 2009

Start date

Jul 15, 2009

Status verified

May 2026

Primary completion

Nov 2, 2018

Completion

Jun 15, 2021

Study Design

Enrollment

506 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (gemcitabine hydrochloride, cisplatin, placebo)
  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.
• Experimental: Arm II (gemcitabine hydrochloride, cisplatin, bevacizumab)
  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.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From date of randomization to date of death due to any cause, assessed up to 7 years ]

Locations (872)

Find similar trials in Birmingham, AL

Related Studies

• Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer
  Recruiting · University of Washington · Seattle, Washington
• Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
  PHASE3 · Recruiting · ECOG-ACRIN Cancer Research Group · Anchorage, Alaska
• Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer
  Recruiting · University of Washington · Baltimore, Maryland
• Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Gainesville, Florida