Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer

Inclusion Criteria

• Patients must consent to be in the study and must have signed and dated an IRB approved consent form conforming to federal and institutional guidelines
• Randomization must occur during the three-week interval beginning on postoperative day 29 and ending on postoperative day 50
• The distal extent of the tumor must be >= 12 cm from the anal verge on endoscopy; if the patient is not a candidate for endoscopy, then the distal extent of the tumor must be >= 12 cm from the anal verge as determined by surgical examination
• The patient must have had an en bloc complete gross resection of tumor (curative resection) by open laparotomy or laparoscopically-assisted colectomy; patients who have had a two-stage surgical procedure, to first provide a decompressive colostomy and then in a later procedure to have the definitive surgical resection, are eligible
• Patients must have histologically confirmed adenocarcinoma of the colon that meets one of the criteria below:
• Stage II carcinoma (T3, 4 N0 M0); the tumor invades through the muscularis propria into the subserosa or into non-peritonealized pericolic or perirectal tissues (T3); or directly invades other organs or structures, and/or perforates visceral peritoneum (T4)
• Stage III carcinoma (any T N1, 2 M0); the tumor has invaded to any depth, with involvement of regional lymph nodes
• Patients with T4 tumors that have involved an adjacent structure (e.g., bladder, small intestine, ovary, etc.) by direct extension from the primary tumor are eligible if all of the following conditions are met:
• All or a portion of the adjacent structure was removed en bloc with the primary tumor
• In the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection")
• Histologic evaluation by the pathologist confirms the margins of the resected specimen are not involved by malignant cells; and
• Local radiation therapy will not be utilized
• Patients with more than one synchronous primary colon tumor are eligible; (staging classification will be based on the more advanced primary tumor)
• Patients must have an ECOG performance status of 0 or 1
• At the time of randomization, postoperative absolute granulocyte count (AGC) must be >= 1500/mm^3 (or = 100,000/mm^3
• Bilirubin must be = ULN, serologic testing for hepatitis B and C must be performed and results must be negative
• Serum creatinine = = 1.0 must undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate = 5 years and are deemed by their physician to be at low risk for recurrence; patients with squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum that have been effectively treated are eligible, even if these conditions were diagnosed within 5 years prior to randomization

Exclusion Criteria

• Patients 150/90 mmHg
• History of TIA or CVA
• History of arterial thrombotic event within 12 months before study entry
• Symptomatic peripheral vascular disease
• PT/INR > 1.5, unless the patient is on therapeutic doses of warfarin. If so, the following criteria must be met for enrollment:
• The subject must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin
• The subject must not have active bleeding or a pathological condition that is associated with a high-risk of bleeding
• Concomitant halogenated antiviral agents
• Clinically significant peripheral neuropathy at the time of randomization (defined in the NCI Common Terminology Criteria for Adverse Events Version 3.0 [CTCAE v3.0] as grade 2 or greater neurosensory or neuromotor toxicity)
• Non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs; specifically excluded are the following cardiac conditions:
• New York Heart Association Class III or IV cardiac disease
• History of myocardial infarction within 12 months before study entry