Bavituximab, Capecitabine, and Radiation Therapy in Treating Patients with Stage II-III Rectal Cancer

Inclusion Criteria

• Biopsy-proven invasive adenocarcinoma of the rectum, stage T3-4 and/or node-positive (American Joint Committee on Cancer [AJCC] stage II or III) per AJCC staging manual, 7th edition; patients with M1a rectal cancer (“metastasis confined to one organ or site [e.g., liver, lung, ovary, non regional node]"), stage IVA disease per the AJCC staging manual, 7th edition, are also eligible; for the purpose of this study, a tumor is located in the “rectum” when its distal edge is located =< 12cm from the anal verge; the distal edge of the tumor can be delineated by digital examination or endoscopic examination, including colonoscopy, although rigid proctoscopy is preferred
• Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale is required
• Leukocytes >= 3,000/mcL
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcl
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
• Creatinine < 1.5 x institutional upper limits of normal
• Activated partial thromboplastin time (aPTT) =< 1.5 x institutional upper limits of normal
• No additional screening intended for human immunodeficiency virus (HIV) or hepatitis infection
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: ** Has not undergone a hysterectomy or bilateral oophorectomy ** Or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

• Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand disease or hemophilia)
• Bleeding * Clinically significant bleeding, such as gross hematuria, gastrointestinal bleeding (excluding bleeding from rectal tumor), and hemoptysis within the 12 months before screening; if clinically significant bleeding has occurred within 12 months of screening but the cause has been identified and adequately treated (e.g., cystitis, ulcer), then this exclusion criterion does not apply * Minor biopsy-related bleeding lasting < 24 hours and resolved at least 1 week before Study Day 1 is allowed
• Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary embolism) within 6 months of screening
• Ongoing therapy with oral or parenteral anticoagulants; low-dose anticoagulation to maintain patency of lines is allowed
• Concurrent estrogens, anti-estrogens or progesterone compounds
• Any prior radiation for rectal cancer
• Symptomatic or clinically active brain metastases
• Major surgery within 4 weeks of Study Day 1
• Pregnant or nursing women
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, history of blood clotting abnormalities, or psychiatric illness/social situations that would limit compliance with study requirements
• Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina pectoris within 6 months of screening
• Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis
• Known hypersensitivity to any components of the treatments
• History of malignancy other than non-melanoma skin cancers within 5 years prior to study enrollment
• Subjects receiving other investigational agents thirty days prior to study treatment or during treatment
• History of inflammatory bowel disease