Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
- Conditions
- Bladder CancerUrethral CancerTransitional Cell Cancer of the Renal Pelvis and Ureter
- Registration Number
- NCT00004223
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of docetaxel and gemcitabine in treating patients who have progressive regional or metastatic bladder cancer.
- Detailed Description
OBJECTIVES: I. Determine the response rate of patients with progressive regional or metastatic transitional cell carcinoma of the urothelium and failure of only 1 prior systemic regimen treated with docetaxel and gemcitabine. II. Determine the toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on days 1 and 8. For patients with complete or partial response or stable disease at 3 weeks, treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months through year 2, every 6 months through year 5, and then annually thereafter until disease progression.
PROJECTED ACCRUAL: A total of 22-45 patients will be accrued for this study over 18-21 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (76)
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
Veterans Affairs Medical Center - Palo Alto
🇺🇸Palo Alto, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
CCOP - Colorado Cancer Research Program, Inc.
🇺🇸Denver, Colorado, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Veterans Affairs Medical Center - Gainsville
🇺🇸Gainesville, Florida, United States
Veterans Affairs Medical Center - Tampa (Haley)
🇺🇸Tampa, Florida, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Scroll for more (66 remaining)CCOP - Scottsdale Oncology Program🇺🇸Scottsdale, Arizona, United States