Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II
Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II
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.
OBJECTIVES:
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.
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of 1 of the following sites:
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
No known brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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