Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial with Molecular Correlates

Biopsy-proven, non-recurrent, primary squamous cell or adenocarcinoma of thoracic esophagus (greater than or equal to 20 cm from incisors) or GE junction. Disease must be confined to no greater than 2 cm into the gastric cardia. Biopsy within 42 days prior to registration. Must have T4M0 disease or be either surgically unresectable, as determined by EUS or EGD, or have medically unresectable disease. EUS (or EGD), CT (or MRI) and PET are required within 42 days prior to reg. Patients with clinically resectable adenocarcinoma should be offered enrollment onto S0356. If primary esophageal cancer is less than 26 cm from incisors, must have bronchoscopy and negative cytology within 28 days prior to reg. Specimens must be available for submission and patients must consent to this submission. Measurable or non-measurable disease. X-rays, scans or exams for measurable disease must be completed within 28 days prior to registration and for non-measurable disease within 42 days prior to registration. All disease assessed. Must not have received prior chemo or RT for this disease. No previous resection or attempted resection of an esophageal cancer. Zubrod PS 0-2. Within 28 days prior to reg: ANC greater than or equal to 1,500/mcl; WBC greater than or equal to 3,000/mcl; platelets greater than or equal to 100,000/mcl; hemoglobin greater than or equal to 10 g/dl; serum albumin, bilirubin and alkaline phosphatase less than or equal to IULN; SGOT or SGPT less than or equal to 2.5xIULN; measured or estimated creatinine clearance greater than 50 ml/min. Must not have had severe reaction to previously-administered monoclonal antibodies. Must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method. No prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.