Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer

• Patients participating in this study must have a tumor biopsy taken to confirm the type of tumor.
• Outpatient therapy with cetuximab alone will be given intravenously on week 0.
• During week 1-8 outpatient radiation therapy will be started and continued once per day for 28 treatments or 5 1/2 weeks.
• Outpatient chemotherapy (cisplatin, irinotecan and cetuximab) is given once per week on weeks 1, 2, 4, and 5. Cetuximab alone will be given on weeks 3, 6, 7, and 8.
• A repeat CT scan and PET scan will be performed to restage the tumor on week 8. This is to confirm that the cancer has remained localized.
• Inpatient surgery is scheduled 4 to 8 weeks after completion of chemotherapy and radiation therapy.
• Cetuximab will be restarted within 4 weeks after surgery and continue weekly for 6 months.
• During chemotherapy and radiation therapy, physical exams and vital signs will be performed before each chemotherapy treatment. Routine blood tests will also be performed.
• Between chemotherapy-radiation therapy and surgery a CAT scan of chest, abdomen and pelvis along with a PET scan will be performed.
• After surgery a CAT scan of chest, abdomen and pelvis will be performed every 3 months for 2 years then every 6 months for 3 years. An EGD (upper endoscopy) with biopsy will be done every 6 months for 2 years and then yearly for 3 years. Physical exam, vital signs and routine blood tests will be done every 2 weeks for 6 months, then every 3 months for 1.5 years, and then every 6 months for 3 years.

Inclusion criteria

• 18 years of age or older
• Negative pregnancy test
• Adenocarcinoma or squamous cell carcinoma of the esophagus, including the gastroesophageal junction, histologically confirmed, stage IIA, IIB and III.
• ECOG performance status of 0 or 1.
• Neutrophils greater or equal to 1,500/ul
• Platelets greater or equal to 100,000/ul
• Serum bilirubin less or equal to 1.5mg/ul
• Serum creatinine less or equal to 1.5mg/ul
• AST or SGOT less or equal to 2.5x upper normal limit
• Alkaline phosphatase less or equal to 5x upper normal limit

Exclusion criteria

• Prior surgery for esophageal or gastro-esophageal junction cancer.
• Prior chemotherapy or radiation therapy
• Biopsy proven tumor invasion of the tracheobronchial tree or tracheo-esophageal fistula.
• Metastatic disease to distant organs or non-regional lymph nodes.
• Co-morbid disease that in the opinion of the investigator makes combined chemo-radiotherapy inadvisable.
• Pregnant or lactating women
• Other active malignancy
• Patients with known Gilbert's Disease or interstitial pulmonary fibrosis.
• History of seizure disorder
• Uncontrolled diarrhea
• Peripheral neuropathy (Grade 2)
• Prior cetuximab or other therapy that specifically and directly targets the EGF pathway.