Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00003809
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether cisplatin plus monoclonal antibody therapy is more effective than cisplatin alone for metastatic or recurrent head and neck cancer.
PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of cisplatin with or without monoclonal antibody in treating patients who have metastatic or recurrent head and neck cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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 (76)
University of Pittsburgh Cancer Institute
πΊπΈPittsburgh, Pennsylvania, United States
Sylvester Cancer Center, University of Miami
πΊπΈMiami, Florida, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
πΊπΈIndianapolis, Indiana, United States
Veterans Affairs Medical Center - Minneapolis
πΊπΈMinneapolis, Minnesota, United States
CCOP - Southern Nevada Cancer Research Foundation
πΊπΈLas Vegas, Nevada, United States
Veterans Affairs Medical Center - Nashville
πΊπΈNashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
πΊπΈNashville, Tennessee, United States
CCOP - Colorado Cancer Research Program, Inc.
πΊπΈDenver, Colorado, United States
Emory University Hospital - Atlanta
πΊπΈAtlanta, Georgia, United States
Stanford University Medical Center
πΊπΈStanford, California, United States
Beckman Research Institute, City of Hope
πΊπΈLos Angeles, California, United States
Veterans Affairs Medical Center - Gainsville
πΊπΈGainesville, Florida, United States
CCOP - Illinois Oncology Research Association
πΊπΈPeoria, Illinois, United States
CCOP - Evanston
πΊπΈEvanston, Illinois, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
πΊπΈDecatur, Georgia, United States
CCOP - Central Illinois
πΊπΈDecatur, Illinois, United States
Indiana University Cancer Center
πΊπΈIndianapolis, Indiana, United States
Johns Hopkins Oncology Center
πΊπΈBaltimore, Maryland, United States
Beth Israel Deaconess Medical Center
πΊπΈBoston, Massachusetts, United States
University of Pennsylvania Cancer Center
πΊπΈPhiladelphia, Pennsylvania, United States
CCOP - Toledo Community Hospital Oncology Program
πΊπΈToledo, Ohio, United States
MBCCOP - San Juan
π΅π·San Juan, Puerto Rico
CCOP - Marshfield Medical Research and Education Foundation
πΊπΈMarshfield, Wisconsin, United States
Pretoria Academic Hospitals
πΏπ¦Pretoria, South Africa
Mayo Clinic Cancer Center
πΊπΈRochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
πΊπΈOmaha, Nebraska, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
πΊπΈMilwaukee, Wisconsin, United States
CCOP - Scottsdale Oncology Program
πΊπΈScottsdale, Arizona, United States
CCOP - Christiana Care Health Services
πΊπΈWilmington, Delaware, United States
Veterans Affairs Medical Center - Palo Alto
πΊπΈPalo Alto, California, United States
Veterans Affairs Medical Center - Lakeside Chicago
πΊπΈChicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
πΊπΈChicago, Illinois, United States
Walter Reed Army Medical Center
πΊπΈWashington, District of Columbia, United States
CCOP - Carle Cancer Center
πΊπΈUrbana, Illinois, United States
CCOP - Wichita
πΊπΈWichita, Kansas, United States
CCOP - Cedar Rapids Oncology Project
πΊπΈCedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
πΊπΈDes Moines, Iowa, United States
New England Medical Center Hospital
πΊπΈBoston, Massachusetts, United States
CCOP - Kalamazoo
πΊπΈKalamazoo, Michigan, United States
CCOP - Metro-Minnesota
πΊπΈSaint Louis Park, Minnesota, United States
Cancer Institute of New Jersey
πΊπΈNew Brunswick, New Jersey, United States
CCOP - Northern New Jersey
πΊπΈHackensack, New Jersey, United States
Hackensack University Medical Center
πΊπΈHackensack, New Jersey, United States
Riverview Medical Center
πΊπΈRed Bank, New Jersey, United States
Veterans Affairs Medical Center - Albany
πΊπΈAlbany, New York, United States
St. Francis Medical Center
πΊπΈTrenton, New Jersey, United States
CCOP - Merit Care Hospital
πΊπΈFargo, North Dakota, United States
Veterans Affairs Medical Center - New York
πΊπΈNew York, New York, United States
Veterans Affairs Medical Center - Brooklyn
πΊπΈBrooklyn, New York, United States
Ireland Cancer Center
πΊπΈCleveland, Ohio, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
πΊπΈNew York, New York, United States
University of Rochester Cancer Center
πΊπΈRochester, New York, United States
CCOP - Sooner State
πΊπΈTulsa, Oklahoma, United States
CCOP - Columbus
πΊπΈColumbus, Ohio, United States
Veterans Affairs Medical Center - Cleveland
πΊπΈCleveland, Ohio, United States
CCOP - Geisinger Clinic and Medical Center
πΊπΈDanville, Pennsylvania, United States
Penn State Geisinger Cancer Center
πΊπΈHershey, Pennsylvania, United States
Hahnemann University Hospital
πΊπΈPhiladelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
πΊπΈPhiladelphia, Pennsylvania, United States
CCOP - MainLine Health
πΊπΈWynnewood, Pennsylvania, United States
Veterans Affairs Medical Center - Pittsburgh
πΊπΈPittsburgh, Pennsylvania, United States
CCOP - Sioux Community Cancer Consortium
πΊπΈSioux Falls, South Dakota, United States
Veterans Affairs Medical Center - Madison
πΊπΈMadison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
πΊπΈMadison, Wisconsin, United States
Albert Einstein Comprehensive Cancer Center
πΊπΈBronx, New York, United States
Mayo Clinic Scottsdale
πΊπΈScottsdale, Arizona, United States
H. Lee Moffitt Cancer Center and Research Institute
πΊπΈTampa, Florida, United States
Veterans Affairs Medical Center - Tampa (Haley)
πΊπΈTampa, Florida, United States
CCOP - Ann Arbor Regional
πΊπΈAnn Arbor, Michigan, United States
CCOP - Duluth
πΊπΈDuluth, Minnesota, United States
Veterans Affairs Medical Center - San Juan
π΅π·San Juan, Puerto Rico
Fox Chase Cancer Center
πΊπΈPhiladelphia, Pennsylvania, United States
Medical College of Wisconsin
πΊπΈMilwaukee, Wisconsin, United States
Yale Comprehensive Cancer Center
πΊπΈNew Haven, Connecticut, United States
MBCCOP - LSU Medical Center
πΊπΈNew Orleans, Louisiana, United States
CCOP - Ochsner
πΊπΈNew Orleans, Louisiana, United States