Combination Chemotherapy 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. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin plus fluorouracil are more effective than paclitaxel plus cisplatin in treating patients with advanced head and neck cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with advanced head and neck cancer.
Head and Neck Cancer
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A RANDOMIZED PHASE III EVALUATION OF PACLITAXEL + G-CSF + CISPLATIN VERSUS CISPLATIN + 5-FU IN ADVANCED HEAD AND NECK CANCER|
|Study Start Date:||March 1997|
OBJECTIVES: I. Compare the response rate, toxicity, quality-of-life, and overall survival at 1 year in patients with advanced head and neck carcinomas when treated with paclitaxel and cisplatin vs cisplatin and fluorouracil. II. Compare these regimens in terms of quality of life and correlate quality of life to toxicity in these patients. III. Compare these regimens in terms of pain intensity and correlate pain with quality of life and toxicity in these patients.
OUTLINE: This is a randomized study. Patients are stratified by disease status, performance status, and participating institution. Patients are randomized to one of two treatment arms. Arm I: Patients receive cisplatin IV over 30-120 minutes on day 1 and fluorouracil IV over 96 hours on days 1-4. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 30-120 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Treatment continues until 2 courses past complete response (minimum of 6 courses). Patients with stable disease may discontinue treatment after 6 courses. Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 212 patients will be accrued for this study over 2.25 years.
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|Study Chair:||Arlene A. Forastiere, MD||Sidney Kimmel Comprehensive Cancer Center|
|Study Chair:||Maha Hadi A. Hussain, MD||Barbara Ann Karmanos Cancer Institute|