Bevacizumab, Fluorouracil, Leucovorin Calcium, and Oxaliplatin Before Surgery in Treating Patients With Stage II-III Rectal Cancer

Inclusion Criteria

• •Histologically confirmed adenocarcinoma of the rectum in patients with no prior therapy who are candidate for surgical resection
• •Tumor lesion is 5-15 cm from anal verge
• •cT2 N+ or cT3-T4 N0 or N+ as assessed by endorectal ultrasound scan (US)
• •No evidence of distant metastatic disease
• •Signed informed consent prior to initiation of any study-specific procedure or treatment
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• •Able to comply with the protocol, including tissue sampling, imaging studies and surgical intervention
• •Life expectancy more than 12 weeks
• •Absolute neutrophil count \>= 1500 per mm\^3
• •Platelet count \>= 100,000 per mm\^3
• •Hemoglobin \>= 9 g/dL (may be transfused to maintain or exceed this level)
• •Total bilirubin \< 1.5 x upper limit of normal (ULN)
• •Aspartate aminotransferase and alanine aminotransferase \< 2.5 x ULN
• •Calculated creatinine clearance according to Cockroft and Gault formula \>= 50 mL/min
• •Urine for proteinuria should be \< 2 +; patients discovered to have \>= 2 + proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate \< 1 g of protein in 24 hours
• •International normalized ratio =\< 1.5 and activated prothrombin time =\< 1.5 x ULN within 7 days prior to enrollment; the use of full-dose oral or parenteral anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits (according to the medical standard of the enrolling institution) and the patient has been on a stable dose of anticoagulants for at least two weeks prior to the first study treatment
• •Female patients should not be pregnant or breast-feeding. Female patients, if not postmenopausal (\< 12 months of amenorrhea) or surgically sterile, should agree to use effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of at least 6 months following the last administration of study drugs. Female patients with an intact uterus (unless amenorrheic for the last 24 months) must have a negative serum pregnancy test within 7 days prior to randomization into the study
• •Fertile male patients must agree to use a highly effective contraceptive method (i.e., with a failure rate of \< 1 % per year, such as vasectomy, sexual abstinence, or female partner's use of hormonal implants or combined oral contraceptives) during the trial and for a period of at least 6 months after the last dose of study drug
• •Archival tumor tissue sample must be requested and available prior to study entry; a copy of the local pathology report must be submitted along with the specimens; patients without available archival tissue are excluded