RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following
surgery in treating patients with stage II bladder cancer.
OBJECTIVES: I. Determine the efficacy of combination chemotherapy with methotrexate,
vinblastine, doxorubicin, and cisplatin (MVAC) following aggressive transurethral resection
of bladder tumors in patients with stage II transitional cell carcinoma of the bladder
without nuclear overexpression of mutant p53. II. Determine the proportion of patients
treated with this regimen in whom bladder preservation rather than radical cystectomy is
OUTLINE: All patients undergo complete or near complete transurethral resection of the
bladder tumor at entry or within 6 weeks prior to entry. Upon confirmation of staging and
histology, patients receive combination chemotherapy with methotrexate, vinblastine,
doxorubicin, and cisplatin (MVAC) every 21 days for 4 courses. Subcutaneous G-CSF is given
with each course. Patients with a complete response after chemotherapy proceed to
intravesical therapy or observation; those with a partial response, stable disease, or
progression proceed to definitive surgery.
PROJECTED ACCRUAL: 30 patients will be entered over approximately 18 months.
DISEASE CHARACTERISTICS: Invasive transitional cell carcinoma of the bladder that is
clinical stage T2-3a N0 M0 by cystoscopy Cystoscopy performed at Memorial Sloan-Kettering
Cancer Center (MSKCC) No multifocal carcinoma in situ No obstructive uropathy or palpable
mass Pathologic confirmation of histology and no more than 20% positive expression of
nuclear p53, as follows: On study following transurethral resection of the bladder (TURB)
OR At TURB performed within 6 weeks of entry as part of initial staging
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100%
Hematopoietic: WBC at least 3,500 Platelets greater than 150,000 Hepatic: Bilirubin less
than 2.0 mg/dL Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than
60 mL/min per 1.73 square meters Cardiovascular: No NYHA class III/IV status Other: No
concomitant malignancy other than basal cell skin carcinoma Negative pregnancy test
required of fertile women Adequate contraception required of fertile women
PRIOR CONCURRENT THERAPY: No prior systemic chemotherapy No prior bladder irradiation