Phase III Randomized Trial of Methotrexate vs. Paclitaxel in Cisplatin-Ineligible Patients With Advanced Squamous Cell Carcinoma of the Head and Neck
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Corey J. Langer, MD
Study Chair
Fox Chase Cancer Center
United States: Federal Government
CDR0000066662
NCT00003592
September 1998
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago, Illinois 60611 |
Veterans Affairs Medical Center - Nashville | Nashville, Tennessee 37212 |