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

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving gemcitabine together with oxaliplatin works compared to gemcitabine alone in treating patients with locally advanced or metastatic bladder cancer.

Detailed Description
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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.

Official Title
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Phase 2 Randomized Study Evaluating the Efficacy of Gemcitabine With or Without Oxaliplatin in Patients With Advanced Urothelial Cancer That Cannot be Treated With Cisplatin-based Chemotherapy

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: gemcitabine hydrochloride
* Drug: oxaliplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine hydrochloride|nan|
|Drug: oxaliplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  |  | 
| Overall survival |  |  | 
| Progression-free survival |  |  | 
| Quality of life as assessed by QLQ-C30 and QLQ-LC13 |  |  | 
| Duration of response |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder