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.
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.
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
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There are 131 Locations for this study
Mobile Alabama, 36652, United States
Anchorage Alaska, 99508, United States
Little Rock Arkansas, 72205, United States
Castro Valley California, 94546, United States
Hayward California, 94545, United States
Los Angeles California, 90089, United States
Oakland California, 94602, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Pleasanton California, 94588, United States
Sacramento California, 95817, United States
San Pablo California, 94806, United States
Aurora Colorado, 80045, United States
Denver Colorado, 80204, United States
Denver Colorado, 80220, United States
Fort Collins Colorado, 80524, United States
Montrose Colorado, 81401, United States
Wheat Ridge Colorado, 80033, United States
Atlanta Georgia, 30309, United States
Atlanta Georgia, 30342, United States
Atlanta Georgia, 30342, United States
Atlanta Georgia, 30342, United States
Austell Georgia, 30106, United States
Decatur Georgia, 30033, United States
Gainesville Georgia, 30501, United States
Lawrenceville Georgia, 30045, United States
Marietta Georgia, 30060, United States
Riverdale Georgia, 30274, United States
Savannah Georgia, 31403, United States
Valdosta Georgia, 31603, United States
Decatur Illinois, 62526, United States
Elgin Illinois, 60120, United States
Springfield Illinois, 62781, United States
Beech Grove Indiana, 46107, United States
Richmond Indiana, 47374, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Kansas City Kansas, 64128, United States
Kingman Kansas, 67068, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67042, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67203, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Lexington Kentucky, 40536, United States
Boston Massachusetts, 02118, United States
Ann Arbor Michigan, 48109, United States
Battle Creek Michigan, 49017, United States
Bay City Michigan, 48708, United States
Big Rapids Michigan, 49307, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49506, United States
Holland Michigan, 49423, United States
Muskegon Michigan, 49442, United States
Pontiac Michigan, 48341, United States
Traverse City Michigan, 49684, United States
Kansas City Missouri, 64131, United States
Springfield Missouri, 65802, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59801, United States
Missoula Montana, 59804, United States
Missoula Montana, 59807, United States
Missoula Montana, 59807, United States
Kearney Nebraska, 68848, United States
Rochester New York, 14623, United States
Rochester New York, 14642, United States
Asheboro North Carolina, 27203, United States
Asheville North Carolina, 28801, United States
Charlotte North Carolina, 28233, United States
Eden North Carolina, 27288, United States
Goldsboro North Carolina, 27534, United States
Goldsboro North Carolina, 27534, United States
Greensboro North Carolina, 27403, United States
Reidsville North Carolina, 27320, United States
Rutherfordton North Carolina, 28139, United States
Wilson North Carolina, 27893, United States
Winston-Salem North Carolina, 27103, United States
Cincinnati Ohio, 45267, United States
Dayton Ohio, 45405, United States
Dayton Ohio, 45406, United States
Dayton Ohio, 45409, United States
Dayton Ohio, 45415, United States
Dayton Ohio, 45428, United States
Dayton Ohio, 45429, United States
Findlay Ohio, 45840, United States
Kettering Ohio, 45429, United States
Middletown Ohio, 45044, United States
Troy Ohio, 45373, United States
Wright-Patterson Air Force Base Ohio, 45433, United States
Xenia Ohio, 45385, United States
Youngstown Ohio, 44501, United States
Gresham Oregon, 97030, United States
Milwaukie Oregon, 97222, United States
Portland Oregon, 97210, United States
Portland Oregon, 97213, United States
Portland Oregon, 97225, United States
Portland Oregon, 97225, United States
Portland Oregon, 97227, United States
Portland Oregon, 97239, United States
Salem Oregon, 97309, United States
Tualatin Oregon, 97062, United States
Anderson South Carolina, 29621, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29601, United States
Greenville South Carolina, 29615, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Fort Sam Houston Texas, 78234, United States
Lackland Air Force Base Texas, 78236, United States
Temple Texas, 76508, United States
Danville Virginia, 24541, United States
Bellingham Washington, 98225, United States
Bremerton Washington, 98310, United States
Mount Vernon Washington, 98273, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98112, United States
Seattle Washington, 98122, United States
Seattle Washington, 98122, United States
Seattle Washington, 98195, United States
Sedro-Woolley Washington, 98284, United States
Spokane Washington, 99202, United States
Vancouver Washington, 98668, United States
Wenatchee Washington, 98801, United States
Yakima Washington, 98902, United States
Sheridan Wyoming, 82801, United States
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