Bevacizumab, Erlotinib and 5-Fluorouracil With External Beam Radiation Therapy in Locally Advanced Rectal Cancer

Inclusion Criteria: * Histologically confirmed primary adenocarcinoma of the rectum that begins within 15cm of the anal verge as determined by sigmoidoscopy or colonoscopy * Clinical T3 or T4 tumors as determined by endoscopic ultrasound and/or rectal MRI * ECOG performance status of 0-2 * 18 years of age or older * Creatinine of \< 2.0 * Adequate hepatic function * Adequate hematopoietic function * Use of effective means of contraception in subjects of child-bearing potential Exclusion Criteria: * Evidence of metastatic disease as determined by chest/abdominal/pelvic CT or physical exam * Prior chemotherapy or radiation therapy for treatment of colorectal cancer * Prior treatment with 5-FU * Prior treatment with a tyrosine kinase inhibitor, EGFR inhibitor, or VEGF inhibitor * Patients must not be receiving any other investigational agent * Prior malignancy within the last 5 years except for completely excised skin cancer, in situ cervical cancer * Warfarin anticoagulation * Co-existent malignant disease * Current or recent participation in a clinical trial (within 4 weeks from the first day of treatment) * Pregnancy * Blood pressure of \>150/100 mmHg * Unstable angina * NYHA Grade II or greater congestive heart failure * History of myocardial infarction within 6 months * History of stroke within 6 months * Clinically significant peripheral vascular disease * Evidence of bleeding diathesis or coagulopathy * Presence of central nervous system or brain metastases * Major surgical procedure, open biopsy, or significant trauma injury within 28 days prior to day 0, anticipation of need for major surgical procedure during the course of the study * Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0 * Pregnant or lactating * Urine protein:creatinine ratio \> or equal to one at screening * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 0\] * Serious, non-healing wound, ulcer, or bone fracture