Bladder Cancer Clinical Trial
Official title:
A Phase II Study of Oxaliplatin in Urothelial Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who
have metastatic bladder cancer.
OBJECTIVES: I. Determine the response rate, duration of response, and overall survival of
patients with metastatic urothelial carcinoma treated with oxaliplatin. II. Determine the
toxicity, including objective measurement of neurotoxicity, of oxaliplatin in these patients
treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified by platinum therapy status
(platinum sensitive vs platinum resistant). Patients receive oxaliplatin IV over 2 hours on
day 1. Courses repeat every 3 weeks in the absence of disease progression, other illness
that would preclude administration of study drug, or unacceptable toxicity. Patients are
followed for a minimum of 2 years or until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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