Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and Neck
NCT ID: NCT00084318
Last Updated: 2018-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
238 participants
INTERVENTIONAL
2004-04-30
2016-12-31
Brief Summary
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PURPOSE: This randomized phase II trial is studying adjuvant cetuximab given together with chemoradiotherapy using cisplatin to see how well it works compared to adjuvant cetuximab given together with chemoradiotherapy using docetaxel in treating patients with resected stage III or stage IV squamous cell carcinoma (cancer) or lymphoepithelioma of the head and neck.
Detailed Description
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Primary
* Compare disease-free survival of patients with resected stage III or IV squamous cell carcinoma or lymphoepithelioma of the head and neck treated with adjuvant cetuximab in combination with chemoradiotherapy comprising docetaxel vs cisplatin.
Secondary
* Compare the safety and efficacy of these regimens in these patients.
* Compare locoregional control and overall survival rates in patients treated with these regimens.
* Correlate epidermal growth factor receptor (total and phosphorylated), pMAPK, pAKT, Stat-3, Ki-67, cyclo-oxygenase-2, and cyclin B1 expression with outcome in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Zubrod performance status (0 vs 1), risk category (positive margins vs high risk \[i.e., ≥ 2 positive nodes or extracapsular nodal extension\]) and use of intensity-modulated radiotherapy (no vs yes). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive cetuximab IV over 2 hours on day 1 (week 1). Patients then receive cetuximab IV over 1 hour and cisplatin IV over 1 hour before radiotherapy on days 8, 15, 22, 29, 36, and 43 (weeks 2-7). Patients undergo radiotherapy once daily, 5 days a week, beginning on day 8 for a total of 6 weeks (weeks 2-7).
* Arm II: Patients receive cetuximab and undergo radiotherapy as in arm I. Patients also receive docetaxel IV over 30 minutes before radiotherapy on days 8, 15, 22, 29, 36, and 43 (weeks 2-7).
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within approximately 29 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RT + cisplatin + cetuximab
Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
cetuximab
400 mg/m\^2 intravenously over 120 minutes on day 1 (week 1) followed by 250 mg/m\^2 intravenously over 60 minutes in weeks 2 through 7.
cisplatin
30 mg/m\^2 intravenously infused over over 60 minutes in weeks 2 through 7.
radiation therapy
60 Gy (2 Gy once a day, 5 times a week)
RT + docetaxel + cetuximab
Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
cetuximab
400 mg/m\^2 intravenously over 120 minutes on day 1 (week 1) followed by 250 mg/m\^2 intravenously over 60 minutes in weeks 2 through 7.
docetaxel
15 mg/m\^2 intravenously infused over 30 minutes in weeks 2 through 7.
radiation therapy
60 Gy (2 Gy once a day, 5 times a week)
Interventions
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cetuximab
400 mg/m\^2 intravenously over 120 minutes on day 1 (week 1) followed by 250 mg/m\^2 intravenously over 60 minutes in weeks 2 through 7.
cisplatin
30 mg/m\^2 intravenously infused over over 60 minutes in weeks 2 through 7.
docetaxel
15 mg/m\^2 intravenously infused over 30 minutes in weeks 2 through 7.
radiation therapy
60 Gy (2 Gy once a day, 5 times a week)
Eligibility Criteria
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Inclusion Criteria
* No evidence of distant metastases
* No synchronous or concurrent head and neck primary tumors
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin \> 8.0 g/dL
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), and alkaline phosphatase meeting 1 of the following parameters:
* Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
* Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN
Renal
* Creatinine ≤ 1.5 mg/dL
Cardiovascular
* No unstable angina
* No uncontrolled hypertension
* No myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass surgery or percutaneous transluminal coronary angioplasty)
* No uncontrolled arrhythmia
* No congestive heart failure
* No more than 2 heart-related hospitalizations within the past year
* No other active cardiac disease
Pulmonary
* No more than 2 hospitalizations for chronic obstructive pulmonary disease within the past year
Neurologic
* No pre-existing peripheral neuropathy ≥ grade 2
* No uncontrolled seizure disorder
* No active neurological disease
Other
* No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior anti-epidermal growth factor receptor antibody therapy
Chemotherapy
* More than 3 years since prior cytotoxic chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior head and neck radiotherapy
Surgery
* See Disease Characteristics
Other
* No prior tyrosine kinase inhibitor therapy
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Paul M. Harari, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Merrill S. Kies, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Jeffrey N. Myers, MD, PhD, FACS
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Mobile Infirmary Medical Center
Mobile, Alabama, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn
Scottsdale, Arizona, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
Scottsdale, Arizona, United States
Auburn Radiation Oncology
Auburn, California, United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Providence Holy Cross Cancer Center
Mission Hills, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Radiation Oncology Center - Roseville
Roseville, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Mercy General Hospital
Sacramento, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
Solano Radiation Oncology Center
Vacaville, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States
Hospital of Saint Raphael
New Haven, Connecticut, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
Boca Raton, Florida, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
M.D. Anderson Cancer Center Orlando
Orlando, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
John B. Amos Cancer Center
Columbus, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Wendt Regional Cancer Center at Finley Hospital
Dubuque, Iowa, United States
John D. Cronin Cancer Center
Lexington, Kentucky, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Tulane Cancer Center
Alexandria, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Upper Michigan Cancer Center at Marquette General Hospital
Marquette, Michigan, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
University of Minnesota Medical Center & Children's Hospital - Fairview
Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States
Coborn Cancer Center
Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Park Nicollet Health Services
Saint Louis Park, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Cape Girardeau, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cancer Institute of New Jersey at Cooper University Hospital - Camden
Camden, New Jersey, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, United States
Long Island College Hospital
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Akron City Hospital
Akron, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States
Oregon Health & Science University Cancer Institute
Portland, Oregon, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Dale and Frances Hughes Cancer Center at Pocono Medical Center
East Stroudsburg, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Mercy Cancer Institute at Mercy Hospital
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Guthrie Cancer Center at Guthrie Clinic Sayre
Sayre, Pennsylvania, United States
Mount Nittany Medical Center
State College, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Bon Secours St. Francis Health System
Greenville, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Cottonwood Hospital Medical Center
Murray, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
Latter Day Saints Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center - East Campus
St. George, Utah, United States
Danville Regional Medical Center
Danville, Virginia, United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
St. Joseph Cancer Center
Bellingham, Washington, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, United States
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States
Countries
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References
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Harari PM, Harris J, Kies MS, et al.: Phase II randomized trial of surgery followed by chemoradiation plus cetuximab for high-risk squamous cell carcinoma of the head and neck (RTOG 0234). [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-22, S13, 2007.
Harari PM, Harris J, Kies MS, Myers JN, Jordan RC, Gillison ML, Foote RL, Machtay M, Rotman M, Khuntia D, Straube W, Zhang Q, Ang K. Postoperative chemoradiotherapy and cetuximab for high-risk squamous cell carcinoma of the head and neck: Radiation Therapy Oncology Group RTOG-0234. J Clin Oncol. 2014 Aug 10;32(23):2486-95. doi: 10.1200/JCO.2013.53.9163. Epub 2014 Jul 7.
Other Identifiers
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CDR0000360850
Identifier Type: -
Identifier Source: secondary_id
RTOG-0234
Identifier Type: -
Identifier Source: org_study_id
NCT00414674
Identifier Type: -
Identifier Source: nct_alias