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