A Phase II Study of Oxaliplatin in Urothelial 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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate of Metastatic Urothelial cancer to a single agent oxaliplatin
2 years
No
Walter M. Stadler, MD, FACP
Study Chair
University of Chicago
United States: Federal Government
10020
NCT00004203
February 2000
April 2005
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Evanston Northwestern Health Care | Evanston, Illinois 60201 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
University of Illinois at Chicago | Chicago, Illinois 60612 |
Cancer Care Specialists of Central Illinois, S.C. | Decatur, Illinois 62526 |
Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
Central Illinois Hematology Oncology Center | Springfield, Illinois 62701 |
Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne, Indiana 46885-5099 |
Michiana Hematology/Oncology P.C. | South Bend, Indiana 46617 |
Division of Hematology/Oncology | Park Ridge, Illinois 60068 |