Gemcitabine With Or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed urothelial carcinoma, or transitional cell carcinoma of the bladder or upper urinary tract

  • Locally advanced disease (T4b) or metastatic disease (N2, N3, or M1)
• Unable to receive cisplatin-based chemotherapy due to creatinine clearance 30-60 mL/min or performance status 2
• At least 1 unidimensionally measurable lesion according to RECIST criteria

• No nonmeasurable lesions only, including any of the following:

  • Ascites
  • Pleural or pericardial effusion
  • Bone metastases
  • Lymphangitis
• No symptomatic cerebral metastases unless they have been stabilized

PATIENT CHARACTERISTICS:

• See Disease Characteristics
• Performance status 0-2
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Alkaline phosphatase ≤ 2 times normal (unless bone metastases are present)
• Transaminases ≤ 2 times normal (5 times normal if hepatic metastases present)
• Bilirubin ≤ 1.5 times normal
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for at least 6 months after completion of treatment
• No prior malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer
• No peripheral neuropathy ≥ grade 2
• No uncontrolled infection

• No other medical conditions that could interfere with evaluating tolerability, including any of the following:

  • Congestive heart failure
  • Angina pectoris that cannot be stabilized with medication
  • Myocardial infarction within the past 12 months
  • Serious thromboembolic disease
• No psychologic, social, or geographic reason that would make follow-up impossible

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior chemotherapy for advanced disease
• More than 4 weeks since prior radiotherapy to a target measurable lesion