Cetuximab as a Second Line Therapy in Patients with Metastatic Esophageal Cancer - Phase II

Histologically confirmed adenocarcinoma of the thoracic esophagus or GE junction. Metastatic disease. Disease must be confined to the esophagus and peri-esophageal soft tissue. Tumors at the GE junction must be confined to no greater than 2 cm into the gastric cardia. Measurable disease. Must submit specimens for correlative studies. Must have received exactly one prior regimen of chemotherapy for metastatic or recurrent disease. In addition, may have also received one prior regimen of chemotherapy in the adjuvant or neo-adjuvant setting if administered at time of initial diagnosis with localized disease. At least 28 days must have elapsed since completion of any previous chemotherapy and must have recovered from all toxicities. Must not have received prior cetuximab or other therapy that specifically and directly targets the EGF pathway. May have received prior radiation therapy. At least 28 days must have elapsed since completion of radiation therapy and must have recovered from all toxicities. May have received prior thoraco-abdominal surgery. Must be at least 21 days beyond surgery and recovered from all effects. Chest x-ray within 42 days prior to registration. Performance Status 0 – 2. Granulocyte count greater than or equal to 1,500/mcl. Platelet count greater than or equal to 100,000/mcl. Serum creatinine less than or equal to 1.5 x IULN. Must not have had a prior allergic reaction to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies (HAMA). No known brain metastases. No plans to receive concurrent chemotherapy while on this protocol treatment. Must not be pregnant or nursing. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.