S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
- Conditions
- Esophageal Cancer
- Interventions
- Biological: cetuximab
- Registration Number
- NCT00096031
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Biological therapies such as cetuximab may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cetuximab cetuximab 250 mg/m\^2 on days 1, 8, 15, and 22 of every 28-day cycle.
- Primary Outcome Measures
Name Time Method Overall Survival at 6 Months every 3 weeks while on treatment, then every 3 months Time to death is measured from date of registration to date of death due to any cause.
- Secondary Outcome Measures
Name Time Method Time to Progression every 3 weeks while on treatment, then every 3 months for 3 years Progression free survival is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. Progressive disease is defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Time to Treatment Failure every 3 weeks while on treatment Time to treatment failure is measured from date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment. Progressive disease is defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Trial Locations
- Locations (152)
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
🇺🇸Decatur, Georgia, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Mission Hospitals - Memorial Campus
🇺🇸Asheville, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
🇺🇸Greensboro, North Carolina, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Minor and James Medical, PLLC
🇺🇸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
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
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Saint Rose Hospital
🇺🇸Hayward, 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
Valley Care Medical Center
🇺🇸Pleasanton, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Doctors Medical Center - San Pablo Campus
🇺🇸San Pablo, California, United States
Poudre Valley Hospital
🇺🇸Fort Collins, Colorado, United States
Exempla Lutheran Medical Center
🇺🇸Wheat Ridge, Colorado, United States
Montrose Memorial Hospital Cancer Center
🇺🇸Montrose, Colorado, United States
Northside Hospital Cancer Center
🇺🇸Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta
🇺🇸Atlanta, Georgia, United States
WellStar Cobb Hospital
🇺🇸Austell, 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
Kennestone Cancer Center at Wellstar Kennestone Hospital
🇺🇸Marietta, Georgia, United States
Gwinnett Medical Center
🇺🇸Lawrenceville, Georgia, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
🇺🇸Valdosta, Georgia, United States
Sherman Hospital
🇺🇸Elgin, 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 - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, 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 - Wellington
🇺🇸Wellington, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, 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
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, 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
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Spectrum Health Hospital - Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Metro Health Hospital
🇺🇸Grand Rapids, Michigan, United States
Hackley Hospital
🇺🇸Muskegon, Michigan, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Holland Community Hospital
🇺🇸Holland, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, 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
Bozeman Deaconess Hospital
🇺🇸Bozeman, Montana, United States
Sletten Regional Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸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
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Wayne Radiation Oncology
🇺🇸Goldsboro, North Carolina, United States
John Smith, Jr. - Dalton McMichael Cancer Center at Morehead Memorial Hospital
🇺🇸Eden, North Carolina, United States
Annie Penn Cancer Center
🇺🇸Reidsville, North Carolina, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Wilson Medical Center
🇺🇸Wilson, North Carolina, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
United States Air Force Medical Center - Wright-Patterson
🇺🇸Wright-Patterson Air Force Base, Ohio, United States
Tod Children's Hospital - Forum Health
🇺🇸Youngstown, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Legacy Mount Hood Medical Center
🇺🇸Gresham, Oregon, United States
Providence Milwaukie Hospital
🇺🇸Milwaukie, Oregon, United States
Salem Hospital Regional Cancer Care Services
🇺🇸Salem, Oregon, United States
AnMed Health Cancer Center
🇺🇸Anderson, South Carolina, United States
Legacy Meridian Park Hospital
🇺🇸Tualatin, Oregon, 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
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Wilford Hall Medical Center
🇺🇸Lackland Air Force Base, Texas, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States
Skagit Valley Hospital Cancer Care Center
🇺🇸Mount Vernon, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
Southwest Washington Medical Center Cancer Center
🇺🇸Vancouver, Washington, United States
North Puget Oncology at United General Hospital
🇺🇸Sedro-Woolley, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
🇺🇸Yakima, Washington, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, 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
Legacy Emanuel Hospital and Health Center & Children's Hospital
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Oregon Health & Science University Cancer Institute
🇺🇸Portland, Oregon, United States
Southern Regional Medical Center
🇺🇸Riverdale, Georgia, United States
Deaconess Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
St. James Community Hospital
🇺🇸Butte, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
St. Vincent Healthcare
🇺🇸Billings, Montana, United States
Kalispell Medical Oncology
🇺🇸Kalispell, 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. Peter's Hospital
🇺🇸Helena, Montana, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States