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