A Phase III Randomized Trial of Either M-VAC or Paclitaxel + Carboplatin as Postoperative Adjuvant Therapy in Patients With Muscle-Invasive Transitional Cell Carcinoma of the Bladder at High-Risk for Relapse

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the
bladder or mixed histologies containing a component of transitional cell carcinoma Must
have undergone radical cystectomy and pelvic lymph node dissection within 12 weeks prior
to randomization No evidence of distant metastatic disease on pre- or postoperative
radiographic scans No positive surgical margins in the cystectomy specimen and no known
macroscopic residual disease left at time of cystectomy No bladder sparing surgery May
have undergone continent urinary diversion or neobladder procedure but must have recovered
completely from the effects of surgery Must have muscle-invasive disease on final
pathologic staging and have a primary tumor stage of pT4, any N, M0, or any pT, N+, M0, or
pT3b, any N, any M, and following a pelvic lymph node dissection have a pathologic nodal
stage of pN0 (only if pT3b or pT4), pN1, or pN2 Clinically unsuspected organ confined
prostate cancer found during cystoprostatectomy allowed

PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater
than 2 times ULN Renal: Creatinine no greater than 1.7 mg/dL OR Creatinine clearance at
least 60 mL/min Cardiovascular: No second degree atrioventricular block or bundle branch
block Other: No history of prior malignancy in the past 5 years except basal or squamous
cell carcinoma of the skin or carcinoma in situ of the cervix No active infection
requiring antibiotics No history of allergic reaction to drugs utilizing the vehicle
Cremophor Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Recovered from all prior therapies Biologic therapy: No prior
biologic response modifier therapy No filgrastim (G-CSF) 24 hours pre- or
post-chemotherapy administration Chemotherapy: No prior systemic chemotherapy Endocrine
therapy: Not specified Radiotherapy: No prior radiotherapy as a component of bladder
sparing therapy No prior adjuvant radiotherapy for locally advanced disease with positive
margins Surgery: See Disease Characteristics Other: Prior intravesical therapy for
superficial bladder cancer allowed and recovered