Bladder Cancer Clinical Trial
Official title:
Phase II Trial of Adjuvant Gemcitabine Plus Cisplatin With Amifostine Cytoprotection in Patients With Locally Advanced Bladder Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal
cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, cisplatin, and
amifostine following surgery in treating patients who have locally advanced bladder cancer.
OBJECTIVES:
- 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
toxicity.
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
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