S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
NCT ID: NCT00096031
Last Updated: 2018-09-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2004-10-31
2010-01-31
Brief Summary
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PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.
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Detailed Description
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* Determine the 6-month overall survival of patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with cetuximab as second-line therapy.
* Determine the response rate (confirmed and unconfirmed, complete and partial), time to progression, and time to treatment failure in patients treated with this drug.
* Determine the toxicity of this drug in these patients.
* Correlate, preliminarily, gene expression and germline polymorphism of enzymes and genes involved in the epidermal growth factor receptor pathway, DNA repair, and angiogenesis with time to progression, response, overall survival, toxic effects, and time to treatment failure in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1-2 hours on day 1. Treatment repeats once weekly in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months until 3 years from the date of study registration.
PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study within 6-14 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cetuximab
250 mg/m\^2 on days 1, 8, 15, and 22 of every 28-day cycle.
cetuximab
1 time Cetuximab 400mg/m2 IV over 120 minutes followed by weekly Cetuximab 250mg/m2 IV over 60 minutes.
Interventions
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cetuximab
1 time Cetuximab 400mg/m2 IV over 120 minutes followed by weekly Cetuximab 250mg/m2 IV over 60 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed adenocarcinoma of 1 of the following sites:
* Thoracic esophagus, located \> 20 cm\* from the incisors
* Gastroesophageal junction, located ≤ 2 cm into the gastric cardia NOTE: \*Tumors located \< 26 cm from the incisors must be confirmed by bronchoscopy and negative cytology
* Disease confined to the esophagus and periesophageal soft tissue
* Metastatic disease
* Measurable disease by x-ray, scanning, or physical examination
* Received exactly 1 prior chemotherapy regimen for metastatic or recurrent disease
* One prior adjuvant or neoadjuvant chemotherapy regimen allowed if administered at the time of initial diagnosis with localized disease
* No known brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Not specified
Renal
* Creatinine ≤ 1.5 times upper limit of normal
Other
* No prior allergic reaction to chimerized or murine monoclonal antibodies
* No evidence of human anti-mouse antibodies (HAMA)
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior cetuximab
Chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy and recovered
* No concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* At least 4 weeks since prior radiotherapy and recovered
Surgery
* At least 3 weeks since prior thoraco-abdominal surgery and recovered
Other
* No other prior therapy that specifically targets the epidermal growth factor pathway
* No other concurrent investigational agents
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Philip J. Gold, MD
Role: STUDY_CHAIR
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Syma Iqbal, MD
Role: STUDY_CHAIR
University of Southern California
Locations
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Mobile Infirmary Medical Center
Mobile, Alabama, United States
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Eden Medical Center
Castro Valley, California, United States
Saint Rose Hospital
Hayward, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Highland General Hospital at St. George's University School of Medicine
Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Valley Care Medical Center
Pleasanton, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Doctors Medical Center - San Pablo Campus
San Pablo, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States
Denver Health Medical Center
Denver, Colorado, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Montrose Memorial Hospital Cancer Center
Montrose, Colorado, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States
Piedmont Hospital
Atlanta, Georgia, United States
Northside Hospital Cancer Center
Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
WellStar Cobb Hospital
Austell, Georgia, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Gwinnett Medical Center
Lawrenceville, Georgia, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, United States
Southern Regional Medical Center
Riverdale, Georgia, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Valdosta, Georgia, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Sherman Hospital
Elgin, Illinois, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Kansas, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States
Bay Regional Medical Center
Bay City, Michigan, United States
Mecosta County Medical Center
Big Rapids, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, 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
Spectrum Health Hospital - Butterworth Campus
Grand Rapids, Michigan, United States
Metro Health Hospital
Grand Rapids, Michigan, United States
Holland Community Hospital
Holland, Michigan, United States
Hackley Hospital
Muskegon, Michigan, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, 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
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
St. Vincent Healthcare
Billings, Montana, United States
Deaconess Billings Clinic - Downtown
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
St. James Community Hospital
Butte, Montana, United States
Big Sky Oncology
Great Falls, Montana, United States
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States
St. Peter's Hospital
Helena, Montana, United States
Glacier Oncology, PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States
Interlakes Oncology/Hematology PC
Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Randolph Hospital
Asheboro, North Carolina, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
John Smith, Jr. - Dalton McMichael Cancer Center at Morehead Memorial Hospital
Eden, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Wayne Radiation Oncology
Goldsboro, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States
Annie Penn Cancer Center
Reidsville, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Wilson Medical Center
Wilson, North Carolina, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital
Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Cancer Care Center
Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
Blanchard Valley Medical Associates
Findlay, Ohio, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States
Middletown Regional Hospital
Middletown, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Air Force Base, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States
Tod Children's Hospital - Forum Health
Youngstown, Ohio, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States
Oregon Health & Science University Cancer Institute
Portland, Oregon, United States
Salem Hospital Regional Cancer Care Services
Salem, Oregon, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, United States
AnMed Health Cancer Center
Anderson, South Carolina, 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
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Danville Regional Medical Center
Danville, Virginia, United States
St. Joseph Cancer Center
Bellingham, Washington, United States
Olympic Hematology and Oncology
Bremerton, Washington, United States
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Minor and James Medical, PLLC
Seattle, Washington, United States
Group Health Central Hospital
Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
Polyclinic First Hill
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States
Countries
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References
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Gold PJ, Goldman B, Iqbal S, et al.: Cetuximab as second-line therapy in patients with metastatic esophageal cancer: a phase II Southwest Oncology Group study. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-96, 2008.
Other Identifiers
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S0415
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000391201
Identifier Type: -
Identifier Source: org_study_id
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