Preoperative Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma

Inclusion Criteria:

signed informed consent
patients 18 years of age or older
biopsy proven, non-recurrent primary adenocarcinoma of the thoracic esophagus or gastro-esophageal junction, disease confined to esophagus and peri-esophageal soft tissue, tumors at the gastroesophageal junction must be limited to no greater than 2 cm into the gastric cardia
clinical stage T3, N0-1 or T1-2, N1 and M0 or M1a (celiac axis lymph nodes are allowed)
Karnofsky Performance Status of >60%
forced expiratory volume at one second (FeV1) must be >1.0 L
adequate bone marrow reserve equal to or absolute neutrophil count (ANC) > 1500/mcl, total white blood cell count (WBC) > 3000/mcl, platelets >100,000/mcl and hemoglobin > 10.0 g/dl (transfusion permitted)
adequate hepatic function of direct serum bilirubin < 2 times the upper limit of normal, total bilirubin < 1.5 times the upper limit normal, alanine transaminase (ALT), aspartate transaminase (AST) < 2.5 times the upper limit normal, Alkaline phosphatase < 2.5 times the upper limit normal
creatinine clearance > 50 ml/min
female patients of childbearing potential must have a negative serum or urin pregnancy test within 7 days prior to starting therapy

Exclusion Criteria:

no previous resection or attempted resection of an esophageal cancer
women who are pregnant or lactating
life expectancy < 3 months
serious, uncontrolled concurrent infection(s)
prior fluoropyrimidine therapy
prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known Dihydro Pyrimidine Dehydrogenase Deficiency (DPD) deficiency
treatment for other carcinomas within 5 years, except cured non-melanoma skin and treated in-situ cervical cancer
history of or evidence of uncontrolled diabetes
surgical procedure within 6 months of study entry
participation in any investigational drug study within 4 weeks preceding the start of study treatment
prior therapy with andy agent that specifically targets the Epidermal Growth Factor Receptor (EGFR) pathway
prior severe infusion reaction to a monoclonal antibody
acute hepatitis or known HIV
clinically significant cardia disease
evidence of metastases
other serious uncontrolled medical conditions that the investigator feels might compromise study participation
major surgery within 4 weeks of the start of treatment without complete recovery
lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
known, existing uncontrolled coagulopathy
unwillingness to give written informed consent
unwillingness to participate or inability to comply with the protocol for the duration of the study
neuropathy of grade 2 or greater