4B951, Combination Chemotherapy in Treating Patients With Bladder Cancer

DISEASE CHARACTERISTICS:

• Histologically proven organ confined transitional cell carcinoma (TCC) of the bladder

• Must have undergone radical cystectomy and bilateral pelvic lymphadenectomy with pathologic stage from definitive cystectomy specimen of P1, P2a, or P2b and N0, M0 TCC with or without squamous/glandular differentiation (no adenocarcinoma, squamous cell carcinoma, or small cell carcinoma)

• Margins must be negative for invasive or in situ TCC

• In situ TCC in the urethra or ureter(s) allowed provided margins are negative

• Clinical stage T1, T2a, or T2b based on transurethral resection bladder tumor specimen with P0 or PIS and N0, M0 TCC allowed

• Incidental pT2a (Gleason score no greater than 7), pT2b (Gleason score no greater than 7), or pT2c (Gleason score no greater than 7) adenocarcinoma of the prostate allowed

• No invasive tumor into ureter(s) or urethra

• Must have potentially curable disease

• Must register within 9 weeks after surgery

• No metastatic disease by physical exam and chest x-ray or CT scan of the chest

• Eligible for randomization if:

• p53 gene alteration present

• Randomization occurs within 10 weeks after surgery

• Those who are randomized to receive (MVAC) methotrexate, vinblastine, doxorubicin, and cisplatin begin MVAC within 12 weeks after cystectomy

• No metastatic disease by physical exam and chest x-ray or CT scan of the chest

• No prohibitive medical risk for chemotherapy

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• ECOG 0-1 OR

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 4,000/mm^3

• Platelet count at least 150,000/mm^3

Hepatic

• SGOT or SGPT no greater than 2 times normal

• Alkaline phosphatase no greater than 2 times normal

• Bilirubin normal

Renal

• Creatinine no greater than 1.8 mg/dL OR

• Creatinine clearance at least 50 mL/min

• Blood urea nitrogen normal

Cardiovascular

• No serious arrhythmias

• No congestive heart disease with New York Heart Association class III or IV status

• Randomization group:

• Ejection fraction must be at least 50% by MUGA scan if there is a clinical concern regarding the patient's cardiac status

Other

• No other malignancy (including synchronous papillary or invasive upper urinary tract malignancy) within the past 5 years except incidental prostate cancer (found at cystectomy), basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix

• No concurrent advanced medical illness or psychologic disease

• No prohibitive medical risk for chemotherapy

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• No prior systemic chemotherapy for bladder cancer

• At least 5 years since other prior systemic chemotherapy

• Prior intravesical therapy allowed

• Randomization group:

• Prior intravesical therapy allowed if administered prior to cystectomy

Endocrine therapy

• Not specified

Radiotherapy

• No prior pelvic irradiation

Surgery

• See Disease Characteristics