Methotrexate Compared With Paclitaxel in Treating Patients With Advanced Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00003592
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate or paclitaxel is more effective in treating patients with advanced head and neck cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of methotrexate with that of paclitaxel in treating patients who have advanced head and neck cancer that cannot be treated with cisplatin.
- Detailed Description
OBJECTIVES: I. Compare the progression free survival, median survival, and overall survival in cisplatin-ineligible patients with advanced squamous cell carcinoma of the head and neck following weekly outpatient methotrexate (arm I) versus paclitaxel (arm II). II. Compare the response rate of patients in the two treatment arms. III. Compare the Trial Outcome Index scores of patients in the two treatment arms. IV. Compare the weight change, neurologic toxicity, and mucositis scores of patients in the two treatment arms.
OUTLINE: This is a randomized study. Patients are stratified by performance status (0-1 vs 2) and age (less than 60 vs at least 60). Patients are randomized to receive methotrexate IV bolus every week for 4 weeks (arm I) or paclitaxel IV over 1 hour every week for 4 weeks (arm II). All patients receive at least 4 weeks of treatment (1 course). Patients continue treatment for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.
PROJECTED ACCRUAL: There will be 230 patients accrued into this study over 2.4 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 230
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Veterans Affairs Medical Center - Atlanta (Decatur)
πΊπΈDecatur, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
πΊπΈChicago, Illinois, United States
CCOP - Kalamazoo
πΊπΈKalamazoo, Michigan, United States
CCOP - Metro-Minnesota
πΊπΈSaint Louis Park, Minnesota, United States
Albert Einstein Comprehensive Cancer Center
πΊπΈBronx, New York, United States
Ireland Cancer Center
πΊπΈCleveland, Ohio, United States
Fox Chase Cancer Center
πΊπΈPhiladelphia, Pennsylvania, United States
Pretoria Academic Hospital
πΏπ¦Pretoria, South Africa
CCOP - Carle Cancer Center
πΊπΈUrbana, Illinois, United States
Veterans Affairs Medical Center - East Orange
πΊπΈEast Orange, New Jersey, United States
Veterans Affairs Medical Center - Nashville
πΊπΈNashville, Tennessee, United States
CCOP - Missouri Valley Cancer Consortium
πΊπΈOmaha, Nebraska, United States
Emory University Hospital - Atlanta
πΊπΈAtlanta, Georgia, United States
CCOP - Illinois Oncology Research Association
πΊπΈPeoria, Illinois, United States
CCOP - Toledo Community Hospital Oncology Program
πΊπΈToledo, Ohio, United States
University of Rochester Cancer Center
πΊπΈRochester, New York, United States
Vanderbilt Cancer Center
πΊπΈNashville, Tennessee, United States
Medical College of Wisconsin
πΊπΈMilwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
πΊπΈMilwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Chicago (Lakeside)
πΊπΈChicago, Illinois, United States