Phase II Trial of Adjuvant Gemcitabine Plus Cisplatin With Amifostine Cytoprotection in Patients With Locally Advanced Bladder Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100

Life expectancy:

- At least 12 weeks

Hematopoietic:

- WBC at least 3,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9.0 g/dL (transfusion allowed)

Hepatic:

- Bilirubin no greater than 2 times upper limit of normal (ULN)

- AST and ALT no greater than 3 times ULN

Renal:

- Creatinine no greater than 2.0 mg/dL OR

- Creatinine clearance at least 50 mL/min

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 3 months after study
participation

- No active infection

- No serious concurrent systemic disorders that would preclude study participation

- No metastatic cancer in past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent immunotherapy

Chemotherapy:

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy except contraceptives and replacement steroids

Radiotherapy:

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- At least 4 but no more than 8 weeks since radical cystectomy

Other:

- No other concurrent experimental medications