S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
Esophageal Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, recurrent esophageal cancer, stage IV esophageal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Sites / Locations
- Mobile Infirmary Medical Center
- Alaska Regional Hospital Cancer Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Eden Medical Center
- Saint Rose Hospital
- USC/Norris Comprehensive Cancer Center and Hospital
- Highland General Hospital at St. George's University School of Medicine
- Alta Bates Summit Medical Center - Summit Campus
- CCOP - Bay Area Tumor Institute
- Valley Care Medical Center
- University of California Davis Cancer Center
- Doctors Medical Center - San Pablo Campus
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Denver Health Medical Center
- Veterans Affairs Medical Center - Denver
- Poudre Valley Hospital
- Montrose Memorial Hospital Cancer Center
- Exempla Lutheran Medical Center
- Piedmont Hospital
- Northside Hospital Cancer Center
- Saint Joseph's Hospital of Atlanta
- CCOP - Atlanta Regional
- WellStar Cobb Hospital
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Northeast Georgia Medical Center
- Gwinnett Medical Center
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Decatur Memorial Hospital Cancer Care Institute
- Sherman Hospital
- Regional Cancer Center at Memorial Medical Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Reid Hospital & Health Care Services, Incorporated
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Veterans Affairs Medical Center - Kansas City
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- Cancer Research Center at Boston Medical Center
- University of Michigan Comprehensive Cancer Center
- Battle Creek Health System Cancer Care Center
- Bay Regional Medical Center
- Mecosta County Medical Center
- Barbara Ann Karmanos Cancer Institute
- Josephine Ford Cancer Center at Henry Ford Hospital
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Spectrum Health Hospital - Butterworth Campus
- Metro Health Hospital
- Holland Community Hospital
- Hackley Hospital
- St. Joseph Mercy Oakland
- Munson Medical Center
- CCOP - Kansas City
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Deaconess Billings Clinic - Downtown
- Bozeman Deaconess Hospital
- St. James Community Hospital
- Big Sky Oncology
- Sletten Regional Cancer Institute at Benefis Healthcare
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Interlakes Oncology/Hematology PC
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Randolph Hospital
- Mission Hospitals - Memorial Campus
- Presbyterian Cancer Center at Presbyterian Hospital
- John Smith, Jr. - Dalton McMichael Cancer Center at Morehead Memorial Hospital
- Wayne Memorial Hospital, Incorporated
- Wayne Radiation Oncology
- Moses Cone Regional Cancer Center at Wesley Long Community Hospital
- Annie Penn Cancer Center
- Rutherford Hospital
- Wilson Medical Center
- Forsyth Regional Cancer Center at Forsyth Medical Center
- Charles M. Barrett Cancer Center at University Hospital
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Charles F. Kettering Memorial Hospital
- Middletown Regional Hospital
- UVMC Cancer Care Center at Upper Valley Medical Center
- United States Air Force Medical Center - Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Tod Children's Hospital - Forum Health
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Legacy Emanuel Hospital and Health Center & Children's Hospital
- Oregon Health & Science University Cancer Institute
- Salem Hospital Regional Cancer Care Services
- Legacy Meridian Park Hospital
- AnMed Health Cancer Center
- Hollings Cancer Center at Medical University of South Carolina
- Bon Secours St. Francis Health System
- CCOP - Greenville
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Brooke Army Medical Center
- Wilford Hall Medical Center
- CCOP - Scott and White Hospital
- Danville Regional Medical Center
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Skagit Valley Hospital Cancer Care Center
- Fred Hutchinson Cancer Research Center
- Harborview Medical Center
- Minor and James Medical, PLLC
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Southwest Washington Medical Center Cancer Center
- Wenatchee Valley Medical Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
Cetuximab
250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.