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.
- 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.
- Completely resected locally advanced bladder cancer
- T2-4, N0-2
- Post radical cystectomy with no gross residual disease
- No evidence of metastases by CT of chest, abdomen, and pelvis
- 18 and over
- Karnofsky 70-100
- At least 12 weeks
- WBC at least 3,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9.0 g/dL (transfusion allowed)
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST and ALT no greater than 3 times ULN
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance at least 50 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 3 months after study
- No active infection
- No serious concurrent systemic disorders that would preclude study participation
- No metastatic cancer in past 5 years
PRIOR CONCURRENT THERAPY:
- No concurrent immunotherapy
- No other concurrent chemotherapy
- No concurrent hormonal therapy except contraceptives and replacement steroids
- No concurrent radiotherapy
- See Disease Characteristics
- At least 4 but no more than 8 weeks since radical cystectomy
- No other concurrent experimental medications