First Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma of the Bladder With a Combination of Cisplatin-Paclitaxel-Gemcitabine
OBJECTIVES:
- Determine the efficacy and toxicity of cisplatin, paclitaxel, and gemcitabine in
patients with progressive unresectable regional or metastatic transitional cell
carcinoma of the bladder.
- Determine the progression free survival of these patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 1
hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses.
Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 18 months.
Interventional
Primary Purpose: Treatment
Catherine Maulard-Durdux, MD
Study Chair
Hopital Tenon
United States: Federal Government
CDR0000068131
NCT00006118
July 1999
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