A Phase II Study of Oxaliplatin in Patients With Advanced Carcinoma of the Head and Neck
OBJECTIVES: I. Determine the response rate of patients with advanced squamous cell carcinoma
of the head and neck when treated with oxaliplatin. II. Characterize the toxicities and
pharmacokinetics of this drug in this patient population. III. Determine the duration of
response, time to progression, and survival of these patients receiving this drug.
OUTLINE: Patients are stratified according to prior treatment with neoadjuvant chemotherapy
(yes vs no). Patients receive oxaliplatin IV over 2 hours weekly for 4 weeks followed by 2
weeks of rest. Treatment continues every 6 weeks in the absence of unacceptable toxicity or
disease progression. Patients are followed until toxicity resolves or for no less than 30
days.
PROJECTED ACCRUAL: A total of 34-74 patients will be accrued for this study within 17
months.
Interventional
Primary Purpose: Treatment
Chris A. Rhoades, MD
Study Chair
Ohio State University Comprehensive Cancer Center
United States: Federal Government
CDR0000067571
NCT00005035
December 1999
March 2004
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
Evanston Northwestern Health Care | Evanston, Illinois 60201 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
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 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Saint Joseph's Regional Medical Center | South Bend, Indiana 46634-1935 |