Randomized, Double Blind, Placebo Controlled Phase III Evaluation of Cisplatin + Placebo Versus Cisplatin + C225 a Mouse/Human Monoclonal Antibody to the Epidermal Growth Factor Receptor, in Patients With Metastatic and/or Recurrent Squamous Cell Cancer of the Head and Neck
OBJECTIVES: I. Compare the efficacy (survival and response rates) and toxicity of cisplatin
with or without monoclonal antibody C225 in patients with metastatic and/or recurrent
squamous cell head and neck cancer. II. Compare the correlation between epidermal growth
factor receptor density and response and progression-free survival in these patients. III.
Determine the steady state serum levels of monoclonal antibody C225 and the frequency of
human antibody response to this monoclonal antibody in patients treated with the combination
therapy.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to disease status (newly diagnosed vs recurrent) and ECOG status (0 vs
1). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive monoclonal
antibody C225 IV over 2 hours followed 1 hour later by cisplatin IV over 2 hours on day 1 of
course 1. Monoclonal antibody C225 is administered over 1 hour on subsequent courses. Arm
II: Patients receive placebo IV over 2 hours followed 1 hour later by cisplatin as in arm I
on day 1 of course 1. Placebo is administered over 1 hour on subsequent courses. Treatment
continues every 4 weeks for at least 6 courses in the absence of disease progression or
unacceptable toxicity. Arm II patients who develop disease progression may then crossover to
arm I treatment. Patients are followed at 1 and 3 months and then every 3 months until
disease progression.
PROJECTED ACCRUAL: A total of 114 patients will be accrued for this study within 14 months.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Barbara A. Burtness, MD
Study Chair
Yale University
United States: Federal Government
CDR0000066954
NCT00003809
June 1999
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Stanford University Medical Center | Stanford, California 94305-5408 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
MBCCOP - LSU Medical Center | New Orleans, Louisiana 70112 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Colorado Cancer Research Program, Inc. | Denver, Colorado 80209-5031 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
New England Medical Center Hospital | Boston, Massachusetts 02111 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
St. Francis Medical Center | Trenton, New Jersey 08629 |
Veterans Affairs Medical Center - Albany | Albany, New York 12208 |
CCOP - Columbus | Columbus, Ohio 43206 |
Penn State Geisinger Cancer Center | Hershey, Pennsylvania 17033 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
CCOP - Evanston | Evanston, Illinois 60201 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
Veterans Affairs Medical Center - New York | New York, New York 10010 |
CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin 54449 |
Veterans Affairs Medical Center - Pittsburgh | Pittsburgh, Pennsylvania 15240 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Riverview Medical Center | Red Bank, New Jersey 07701 |
Veterans Affairs Medical Center - Palo Alto | Palo Alto, California 94304 |
Veterans Affairs Medical Center - Cleveland | Cleveland, Ohio 44106 |
Veterans Affairs Medical Center - Nashville | Nashville, Tennessee 37212 |
Veterans Affairs Medical Center - Brooklyn | Brooklyn, New York 11209 |
Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
CCOP - Sooner State | Tulsa, Oklahoma 74136 |
Veterans Affairs Medical Center - Gainsville | Gainesville, Florida 32608-1197 |