MVAC (Methotrexate, Vinblastine, Adriamycin, and Cisplatin) in Organ-Confined Bladder Cancer Based on p53 Status

Date de début de l'étude : 1 août 1997

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