Oxaliplatin in Treating Patients With Metastatic Bladder Cancer
- Conditions
- Bladder CancerTransitional Cell Cancer of the Renal Pelvis and Ureter
- Interventions
- Registration Number
- NCT00004203
- Lead Sponsor
- University of Chicago
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A oxaliplatin On Day 1 of each 21-day treatment cycle, patients receive 130 mg/m2 oxaliplatin diluted in 250 to 500 mL Dextrose 5% in Water infused intravenously over 2 hours through a peripheral or central vein
- Primary Outcome Measures
Name Time Method Response Rate of Metastatic Urothelial cancer to a single agent oxaliplatin 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
Cancer Care Specialists of Central Illinois, S.C.
🇺🇸Decatur, Illinois, United States
Evanston Northwestern Health Care
🇺🇸Evanston, Illinois, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Division of Hematology/Oncology
🇺🇸Park Ridge, Illinois, United States
Michiana Hematology/Oncology P.C.
🇺🇸South Bend, Indiana, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Central Illinois Hematology Oncology Center
🇺🇸Springfield, Illinois, United States
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Fort Wayne Medical Oncology and Hematology, Inc.
🇺🇸Fort Wayne, Indiana, United States