Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer

OBJECTIVES:

* Compare the overall, cause-specific, and disease-free survival of patients with high-risk muscle-invasive transitional cell carcinoma of the bladder treated with adjuvant cisplatin and gemcitabine vs observation after radical cystectomy. * Compare the dose intensity and toxicity of two different schedules of cisplatin and gemcitabine in these patients. * Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and disease status (T2 \[G3 only\] or T3-4 \[any G\], N0-2 vs any T, N1-2, M0). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients are further randomized to 1 of 2 treatment regimens.

* Regimen A: Patients receive cisplatin IV on day 2 and gemcitabine IV on days 1, 8, and 15. * Regimen B: Patients receive cisplatin IV on day 15 and gemcitabine as in regimen A.

Treatment in both regimens repeats every 28 days for 4 courses.

* Arm II: Patients undergo observation followed by cisplatin and gemcitabine as in arm I at relapse.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 700 patients (350 per treatment arm) will be accrued for this study within 3 years.