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

OBJECTIVES:

Primary

• Determine the objective response rate in patients with advanced urothelial cancer treated with gemcitabine hydrochloride with vs without oxaliplatin.

Secondary

• Determine the tolerance of these regimens in these patients.
• Determine the overall survival and progression-free survival of patients treated with these regimens.
• Determine the quality of life of patients treated with these regimens.
• Determine the duration of response in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive gemcitabine hydrochloride IV over 120 minutes on days 1, 8, and 15.
• Arm II: Patients receive gemcitabine IV over 100 minutes on days 1 and 15 and oxaliplatin IV over 120 minutes on days 2 and 16.

Treatment in both arms repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

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