Phase 2 Randomized Study Evaluating the Efficacy of Gemcitabine With or Without Oxaliplatin in Patients With Advanced Urothelial Cancer That Cannot be Treated With Cisplatin-based Chemotherapy
- Determine the objective response rate in patients with advanced urothelial cancer
treated with gemcitabine hydrochloride with vs without oxaliplatin.
- Determine the tolerance of these regimens in these patients.
- Determine the overall survival and progression-free survival of patients treated with
- Determine the quality of life of patients treated with these regimens.
- Determine the duration of response in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 120 minutes on days 1, 8, and
- Arm II: Patients receive gemcitabine IV over 100 minutes on days 1 and 15 and
oxaliplatin IV over 120 minutes on days 2 and 16.
Treatment in both arms repeats every 4 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
Allocation: Randomized, Primary Purpose: Treatment
Objective response rate
Damien Pouessel, MD
Centre Val d'Aurelle - Paul Lamarque
United States: Federal Government