Phase II Trial of Adjuvant Gemcitabine Plus Cisplatin With Amifostine Cytoprotection in Patients With Locally Advanced Bladder Cancer
- Determine the toxicity of adjuvant gemcitabine and cisplatin with amifostine
cytoprotection in patients with completely resected locally advanced bladder cancer.
- Compare recurrence rate in these patients when treated with this regimen to historical
control patients who had a cystectomy performed by the same surgeon.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, and cisplatin
IV over 60 minutes and amifostine IV over 15 minutes on day 1. Treatment continues every 28
days for a total of 4 courses in the absence of disease progression or unacceptable
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 19-42 patients will be accrued for this study.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Side effects of cisplatin/gemcitabine in combination with amifostine
Walter M. Stadler, MD, FACP
University of Chicago
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|