Head and Neck Cancer Clinical Trial
Official title:
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
NCT number | NCT00003809 |
Other study ID # | CDR0000066954 |
Secondary ID | ECOG-E5397 |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | August 6, 1999 |
Verified date | June 2023 |
Source | Eastern Cooperative Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | September 2004 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck that is incurable with surgery or radiotherapy No nasopharyngeal primaries Measurable or evaluable disease Newly diagnosed with extensive, incurable local regional disease AND distant metastases OR Local regional recurrence/persistence or distant metastases after surgery or radiotherapy Persistent or progressive disease after radiotherapy must be histologically proven at least 8 weeks after therapy No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 1.2 mg/dL OR Creatinine clearance at least 50 mL/min Calcium no greater than ULN No history of hypercalcemia Other: No active infection No other concurrent malignancy within past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No known hypersensitivity to murine proteins Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior chimeric antibody or kinase inhibitor for recurrent or metastatic disease No more than 1 prior biotherapy regimen for recurrent or metastatic disease Chemotherapy: At least 3 months since prior induction or adjuvant chemotherapy concurrent with radiotherapy No prior chemotherapy for recurrent disease Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Recovered from prior major surgery |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | MBCCOP - San Juan | San Juan | |
Puerto Rico | Veterans Affairs Medical Center - San Juan | San Juan | |
South Africa | Pretoria Academic Hospitals | Pretoria | |
United States | Veterans Affairs Medical Center - Albany | Albany | New York |
United States | CCOP - Ann Arbor Regional | Ann Arbor | Michigan |
United States | Emory University Hospital - Atlanta | Atlanta | Georgia |
United States | Johns Hopkins Oncology Center | Baltimore | Maryland |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | New England Medical Center Hospital | Boston | Massachusetts |
United States | Albert Einstein Comprehensive Cancer Center | Bronx | New York |
United States | Veterans Affairs Medical Center - Brooklyn | Brooklyn | New York |
United States | CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa |
United States | Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago | Illinois |
United States | Veterans Affairs Medical Center - Lakeside Chicago | Chicago | Illinois |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | Veterans Affairs Medical Center - Cleveland | Cleveland | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | CCOP - Geisinger Clinic and Medical Center | Danville | Pennsylvania |
United States | CCOP - Central Illinois | Decatur | Illinois |
United States | Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur | Georgia |
United States | CCOP - Colorado Cancer Research Program, Inc. | Denver | Colorado |
United States | CCOP - Iowa Oncology Research Association | Des Moines | Iowa |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | CCOP - Evanston | Evanston | Illinois |
United States | CCOP - Merit Care Hospital | Fargo | North Dakota |
United States | Veterans Affairs Medical Center - Gainsville | Gainesville | Florida |
United States | CCOP - Northern New Jersey | Hackensack | New Jersey |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Penn State Geisinger Cancer Center | Hershey | Pennsylvania |
United States | Indiana University Cancer Center | Indianapolis | Indiana |
United States | Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana |
United States | CCOP - Kalamazoo | Kalamazoo | Michigan |
United States | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Beckman Research Institute, City of Hope | Los Angeles | California |
United States | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin |
United States | Veterans Affairs Medical Center - Madison | Madison | Wisconsin |
United States | CCOP - Marshfield Medical Research and Education Foundation | Marshfield | Wisconsin |
United States | Sylvester Cancer Center, University of Miami | Miami | Florida |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin |
United States | Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Veterans Affairs Medical Center - Nashville | Nashville | Tennessee |
United States | Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | Yale Comprehensive Cancer Center | New Haven | Connecticut |
United States | CCOP - Ochsner | New Orleans | Louisiana |
United States | MBCCOP - LSU Medical Center | New Orleans | Louisiana |
United States | NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York | New York |
United States | Veterans Affairs Medical Center - New York | New York | New York |
United States | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska |
United States | Veterans Affairs Medical Center - Palo Alto | Palo Alto | California |
United States | CCOP - Illinois Oncology Research Association | Peoria | Illinois |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Hahnemann University Hospital | Philadelphia | Pennsylvania |
United States | Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania |
United States | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania |
United States | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania |
United States | Veterans Affairs Medical Center - Pittsburgh | Pittsburgh | Pennsylvania |
United States | Riverview Medical Center | Red Bank | New Jersey |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | University of Rochester Cancer Center | Rochester | New York |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | CCOP - Scottsdale Oncology Program | Scottsdale | Arizona |
United States | Mayo Clinic Scottsdale | Scottsdale | Arizona |
United States | CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota |
United States | Stanford University Medical Center | Stanford | California |
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
United States | Veterans Affairs Medical Center - Tampa (Haley) | Tampa | Florida |
United States | CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio |
United States | St. Francis Medical Center | Trenton | New Jersey |
United States | CCOP - Sooner State | Tulsa | Oklahoma |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
United States | Walter Reed Army Medical Center | Washington | District of Columbia |
United States | CCOP - Wichita | Wichita | Kansas |
United States | CCOP - Christiana Care Health Services | Wilmington | Delaware |
United States | CCOP - MainLine Health | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Eastern Cooperative Oncology Group | National Cancer Institute (NCI) |
United States, Puerto Rico, South Africa,
Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA; Eastern Cooperative Oncology Group. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperati — View Citation
Burtness BA, Li Yi, Flood W, et al.: Phase III trial comparing cisplatin (C) + placebo (P) to C + anti-epidermal growth factor antibody (EGF-R) C225 in patients (pts) with metastatic/recurrent head & neck cancer (HNC). [Abstract] Proceedings of the Americ
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