Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of Oxaliplatin in Patients With Advanced Carcinoma of the Head and Neck|
|Study Start Date:||December 1999|
|Study Completion Date:||March 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005035
|United States, Illinois|
|Louis A. Weiss Memorial Hospital|
|Chicago, Illinois, United States, 60640|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|Decatur Memorial Hospital Cancer Care Institute|
|Decatur, Illinois, United States, 62526|
|Evanston Northwestern Health Care|
|Evanston, Illinois, United States, 60201|
|Lutheran General Cancer Care Center|
|Park Ridge, Illinois, United States, 60068|
|Oncology/Hematology Associates of Central Illinois, P.C.|
|Peoria, Illinois, United States, 61602|
|Central Illinois Hematology Oncology Center|
|Springfield, Illinois, United States, 62701|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology, Inc.|
|Fort Wayne, Indiana, United States, 46885-5099|
|Saint Joseph's Regional Medical Center|
|South Bend, Indiana, United States, 46634-1935|
|United States, Ohio|
|Arthur G. James Cancer Hospital - Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|United States, South Carolina|
|Cancer Centers of the Carolinas|
|Greenville, South Carolina, United States, 29605|
|Study Chair:||Chris A. Rhoades, MD||Ohio State University Comprehensive Cancer Center|