NCT00004203

Oxaliplatin in Treating Patients With Metastatic Bladder Cancer

A Phase II Study of Oxaliplatin in Urothelial Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bladder Cancer
• Transitional Cell Cancer of the Renal Pelvis and Ureter

Interventions

Type	Name	Description
DRUG	oxaliplatin

Timeline

• Start date: 2000-02-01
• Primary completion: 2002-02-01
• Completion: 2005-04-01
• First posted: 2004-02-12
• Last updated: 2013-09-05

Locations

14 sites across 2 countries: United States, Canada