Esophageal Cancer Clinical Trial

S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

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.

View Full Description

Full 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.

View Eligibility Criteria

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

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

63

Study ID:

NCT00096031

Recruitment Status:

Completed

Sponsor:

Southwest Oncology Group

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There are 131 Locations for this study

See Locations Near You

Mobile Infirmary Medical Center
Mobile Alabama, 36652, United States
Alaska Regional Hospital Cancer Center
Anchorage Alaska, 99508, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Eden Medical Center
Castro Valley California, 94546, United States
Saint Rose Hospital
Hayward California, 94545, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90089, United States
Highland General Hospital at St. George's University School of Medicine
Oakland California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland California, 94609, United States
CCOP - Bay Area Tumor Institute
Oakland California, 94609, United States
Valley Care Medical Center
Pleasanton California, 94588, United States
University of California Davis Cancer Center
Sacramento California, 95817, United States
Doctors Medical Center - San Pablo Campus
San Pablo California, 94806, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora Colorado, 80045, United States
Denver Health Medical Center
Denver Colorado, 80204, United States
Veterans Affairs Medical Center - Denver
Denver Colorado, 80220, United States
Poudre Valley Hospital
Fort Collins Colorado, 80524, United States
Montrose Memorial Hospital Cancer Center
Montrose Colorado, 81401, United States
Exempla Lutheran Medical Center
Wheat Ridge Colorado, 80033, United States
Piedmont Hospital
Atlanta Georgia, 30309, United States
Northside Hospital Cancer Center
Atlanta Georgia, 30342, United States
Saint Joseph's Hospital of Atlanta
Atlanta Georgia, 30342, United States
CCOP - Atlanta Regional
Atlanta Georgia, 30342, United States
WellStar Cobb Hospital
Austell Georgia, 30106, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur Georgia, 30033, United States
Northeast Georgia Medical Center
Gainesville Georgia, 30501, United States
Gwinnett Medical Center
Lawrenceville Georgia, 30045, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta Georgia, 30060, United States
Southern Regional Medical Center
Riverdale Georgia, 30274, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah Georgia, 31403, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Valdosta Georgia, 31603, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur Illinois, 62526, United States
Sherman Hospital
Elgin Illinois, 60120, United States
Regional Cancer Center at Memorial Medical Center
Springfield Illinois, 62781, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove Indiana, 46107, United States
Reid Hospital & Health Care Services, Incorporated
Richmond Indiana, 47374, United States
Cancer Center of Kansas, PA - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado Kansas, 67042, United States
Veterans Affairs Medical Center - Kansas City
Kansas City Kansas, 64128, United States
Cancer Center of Kansas, PA - Kingman
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina Kansas, 67042, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita Kansas, 67203, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington Kentucky, 40536, United States
Cancer Research Center at Boston Medical Center
Boston Massachusetts, 02118, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Battle Creek Health System Cancer Care Center
Battle Creek Michigan, 49017, United States
Bay Regional Medical Center
Bay City Michigan, 48708, United States
Mecosta County Medical Center
Big Rapids Michigan, 49307, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit Michigan, 48202, United States
CCOP - Grand Rapids
Grand Rapids Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids Michigan, 49503, United States
Spectrum Health Hospital - Butterworth Campus
Grand Rapids Michigan, 49503, United States
Metro Health Hospital
Grand Rapids Michigan, 49506, United States
Holland Community Hospital
Holland Michigan, 49423, United States
Hackley Hospital
Muskegon Michigan, 49442, United States
St. Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
Munson Medical Center
Traverse City Michigan, 49684, United States
CCOP - Kansas City
Kansas City Missouri, 64131, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65802, United States
St. John's Regional Health Center
Springfield Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
St. Vincent Healthcare
Billings Montana, 59101, United States
Deaconess Billings Clinic - Downtown
Billings Montana, 59107, United States
Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States
St. James Community Hospital
Butte Montana, 59701, United States
Big Sky Oncology
Great Falls Montana, 59405, United States
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls Montana, 59405, United States
St. Peter's Hospital
Helena Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology
Kalispell Montana, 59901, United States
Community Medical Center
Missoula Montana, 59801, United States
Guardian Oncology and Center for Wellness
Missoula Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59807, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59807, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney Nebraska, 68848, United States
Interlakes Oncology/Hematology PC
Rochester New York, 14623, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
Randolph Hospital
Asheboro North Carolina, 27203, United States
Mission Hospitals - Memorial Campus
Asheville North Carolina, 28801, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte North Carolina, 28233, United States
John Smith, Jr. - Dalton McMichael Cancer Center at Morehead Memorial Hospital
Eden North Carolina, 27288, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
Wayne Radiation Oncology
Goldsboro North Carolina, 27534, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro North Carolina, 27403, United States
Annie Penn Cancer Center
Reidsville North Carolina, 27320, United States
Rutherford Hospital
Rutherfordton North Carolina, 28139, United States
Wilson Medical Center
Wilson North Carolina, 27893, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem North Carolina, 27103, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio, 45267, United States
Grandview Hospital
Dayton Ohio, 45405, United States
Good Samaritan Hospital
Dayton Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton Ohio, 45415, United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio, 45428, United States
CCOP - Dayton
Dayton Ohio, 45429, United States
Blanchard Valley Medical Associates
Findlay Ohio, 45840, United States
Charles F. Kettering Memorial Hospital
Kettering Ohio, 45429, United States
Middletown Regional Hospital
Middletown Ohio, 45044, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy Ohio, 45373, United States
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Air Force Base Ohio, 45433, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia Ohio, 45385, United States
Tod Children's Hospital - Forum Health
Youngstown Ohio, 44501, United States
Legacy Mount Hood Medical Center
Gresham Oregon, 97030, United States
Providence Milwaukie Hospital
Milwaukie Oregon, 97222, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland Oregon, 97210, United States
Providence Cancer Center at Providence Portland Medical Center
Portland Oregon, 97213, United States
CCOP - Columbia River Oncology Program
Portland Oregon, 97225, United States
Providence St. Vincent Medical Center
Portland Oregon, 97225, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland Oregon, 97227, United States
Oregon Health & Science University Cancer Institute
Portland Oregon, 97239, United States
Salem Hospital Regional Cancer Care Services
Salem Oregon, 97309, United States
Legacy Meridian Park Hospital
Tualatin Oregon, 97062, United States
AnMed Health Cancer Center
Anderson South Carolina, 29621, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston South Carolina, 29425, United States
Bon Secours St. Francis Health System
Greenville South Carolina, 29601, United States
CCOP - Greenville
Greenville South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
Wilford Hall Medical Center
Lackland Air Force Base Texas, 78236, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
Danville Regional Medical Center
Danville Virginia, 24541, United States
St. Joseph Cancer Center
Bellingham Washington, 98225, United States
Olympic Hematology and Oncology
Bremerton Washington, 98310, United States
Skagit Valley Hospital Cancer Care Center
Mount Vernon Washington, 98273, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98104, United States
Harborview Medical Center
Seattle Washington, 98104, United States
Minor and James Medical, PLLC
Seattle Washington, 98104, United States
Group Health Central Hospital
Seattle Washington, 98112, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle Washington, 98122, United States
Polyclinic First Hill
Seattle Washington, 98122, United States
University Cancer Center at University of Washington Medical Center
Seattle Washington, 98195, United States
North Puget Oncology at United General Hospital
Sedro-Woolley Washington, 98284, United States
Cancer Care Northwest - Spokane South
Spokane Washington, 99202, United States
Southwest Washington Medical Center Cancer Center
Vancouver Washington, 98668, United States
Wenatchee Valley Medical Center
Wenatchee Washington, 98801, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima Washington, 98902, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

63

Study ID:

NCT00096031

Recruitment Status:

Completed

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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