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Brief Title: Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer
Official Title: A Phase II Study of Oxaliplatin in Patients With Advanced Carcinoma of the Head and Neck
Study ID: NCT00005035
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 advanced head and neck cancer.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital, Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States
Evanston Northwestern Health Care, Evanston, Illinois, United States
Lutheran General Cancer Care Center, Park Ridge, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C., Peoria, Illinois, United States
Central Illinois Hematology Oncology Center, Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne, Indiana, United States
Saint Joseph's Regional Medical Center, South Bend, Indiana, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
Cancer Centers of the Carolinas, Greenville, South Carolina, United States
Name: Chris A. Rhoades, MD
Affiliation: Ohio State University Comprehensive Cancer Center
Role: STUDY_CHAIR