A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgery for Locally-advanced Rectal Cancer

INCLUSION CRITERIA * Histologically-confirmed adenocarcinoma of the rectum. Clinical stages T3; T4; or N1 as determined by endoscopic ultrasound; or a rectal CT or MRI scan are eligible, including T3 N0; T3 N1; T4 N0; T4 N1; T1-4 N1. Rectal cancers are defined as those whose distal border extends to within 12 cm of the anal verge. * Age ≥ 18 * Karnofsky performance status (KPS) ≥ 70 * Leukocyte count \> 3,500 x 10e6/µL * Platelet count \> 100,000/µL * Serum glutamic-oxaloacetic transaminase (SGOT) \< 2.5 x institutional upper limits of normal (ULN) * Serum glutamic-pyruvic transaminase (SGPT) \< 2.5 x ULN * Alkaline phosphatase \< 2.5 x ULN * Total bilirubin \< 1.5x ULN * Creatinine: * Within normal institutional limits * OR * Creatinine clearance \> 60 mL/min/1.73 m2 (if serum creatinine levels above institutional normal) * Ability to swallow pills without difficulty * Women of child-bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG), within 72 hours prior to the start of study medication * Women of child-bearing potential must be using an adequate method of contraception to avoid pregnancy throughout the treatment EXCLUSION CRITERIA * Metastatic (M1) or stage IV disease * Prior history of treatment with cetuximab or other therapy targeting EGFR * Prior history of anti-cancer murine monoclonal antibody therapy * Prior pelvic or whole abdominal radiotherapy * Uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness / social situations that would limit compliance with study requirements * Patients with a concurrent malignancy or previous malignancy within 5 years of screening will be excluded from this study (EXCEPTION: concurrent or previous non-melanoma skin cancer, hematolymphoid malignancy or carcinoma in-situ of the cervix may be allowed at the investigator's discretion) * Inability to sign written consent * Pregnant or breastfeeding * Unwilling or unable to use effective contraception in self or partner for the entire study period and for up to 4 weeks after the study