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

Inclusion Criteria

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