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 combining cisplatin, paclitaxel, and gemcitabine in treating patients who have progressive unresectable regional or metastatic bladder cancer.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Hopital Drevon
Dijon, France
CHR de Grenoble - La Tronche
Grenoble, France
Hopital Perpetuel Secours
Levallois-Perret, France
CHU de la Timone
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Marseille, France
Hopital Notre-Dame de Bon Secours
Metz, France
Hopital Laennec
Paris, France
Hopital Saint Antoine
Paris, France
Hopital Tenon
Paris, France
Polyclinique De Courlancy
Reims, France
C.H. Senlis
Senlis, France
...and 2 more locations