Combination Chemotherapy in Treating Patients With Bladder Cancer
- Conditions
- Bladder Cancer
- Interventions
- Registration Number
- NCT00014534
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy work in 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: Randomized phase III trial to compare different combination chemotherapy regimens in treating patients who have advanced bladder cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare the survival of patients with completely resected locally advanced transitional cell carcinoma of the bladder treated with adjuvant doxorubicin and gemcitabine followed by paclitaxel and cisplatin vs adjuvant cisplatin and gemcitabine.
Secondary
* Compare the toxicity profiles of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to primary tumor status (\<T4 vs T4), number of positive lymph nodes (0 or unknown vs 1-5 vs \>5), and number of dissected nodes (0-10 or unknown vs \> 10). Patients are randomized to one of two treatment arms.
* Arm I: Patients receive adjuvant gemcitabine IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive adjuvant doxorubicin IV over 45 minutes followed by gemcitabine IV over 2 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily on days 3-10. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 14 days after the completion of doxorubicin and gemcitabine, patients receive paclitaxel IV over 3 hours and cisplatin IV over 20-30 minutes on day 1. Patients also receive G-CSF SC daily on days 3-10 or 4-11. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 18 months, every 6 months for 18 months, and then annually thereafter.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gemcitabine + cisplatin cisplatin - Gemcitabine + Doxorubicin + Pegfilgrastim filgrastim - Gemcitabine + Doxorubicin + Pegfilgrastim doxorubicin hydrochloride - Gemcitabine + cisplatin gemcitabine hydrochloride - Gemcitabine + Doxorubicin + Pegfilgrastim gemcitabine hydrochloride -
- Primary Outcome Measures
Name Time Method Overall survival 4 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (285)
CCOP - Mayo Clinic Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Arroyo Grande Community Hospital
🇺🇸Arroyo Grande, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸San Diego, California, United States
Kaiser Permanente Medical Office -Vandever Medical Office
🇺🇸San Diego, California, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
Aurora Presbyterian Hospital
🇺🇸Aurora, Colorado, United States
Boulder Community Hospital
🇺🇸Boulder, Colorado, United States
Scroll for more (275 remaining)CCOP - Mayo Clinic Scottsdale Oncology Program🇺🇸Scottsdale, Arizona, United States