Phase III Study Comparing Sequential Chemotherapy (AG-ITP) To Cisplatin And Gemcitabine As Adjuvant Treatment After Cystectomy For Transitional Cell Carcinoma Of The Bladder

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed transitional cell carcinoma of the bladder

- Any T, N+, M0 OR

- T3a-4a, N0, M0

- At least 6 weeks but no more than 3 months since prior complete resection of bladder

- Cystoprostatectomy plus pelvic lymph node dissection in males

- Cystectomy/total abdominal hysterectomy/bilateral salpingo-oophorectomy plus
pelvic lymph node dissection in females

- Negative surgical margins

- Carcinoma in situ allowed

- No partial cystectomy or transurethral bladder tumor resection as definitive
loco-regional therapy

- Prostate cancer detected in resected specimen allowed if post-operative PSA is no
more than 0.05 mg/dL

- No metastatic or recurrent disease by post-operative chest x-ray and CT scan of
abdomen and pelvis

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 150,000/mm^3

Hepatic:

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2 times ULN

- AST ≤ 2 times ULN

Renal:

- Creatinine ≤ 1.5 mg/dL OR

- Creatinine clearance ≥ 60 mL/min

Cardiovascular:

- Normal cardiac function by history, physical exam, or chest radiograph

- Left ventricular ejection fraction at least 50% by radionuclide ventriculogram or
echocardiogram, for prior cardiac disease

- No New York Heart Association class III or IV heart disease

- No serious cardiac arrhythmias including first-, second-, and third-degree heart
block

Other:

- Negative pregnancy test

- No uncontrolled infection

- No other active cancer within the past 5 years except non-melanoma skin cancer or
curatively treated carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior systemic chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy to bladder

Surgery:

- See Disease Characteristics