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RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil,
work in different ways to stop tumor cells from dividing so they stop growing or die.
Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or
deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also
stop the growth of tumor cells by stopping blood flow to the tumor. Giving chemotherapy
together with bevacizumab may kill more tumor cells. It is not yet known whether treatment
with oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab
in treating patients who have undergone surgery for colon cancer.
PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin, and
fluorouracil together with bevacizumab to see how well it works compared to oxaliplatin,
leucovorin, and fluorouracil alone in treating patients who have undergone surgery for stage
II or stage III colon cancer.
Active, not recruiting
Ages:18 and older
DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the colon, meeting 1 of the following stage criteria: - Stage II disease (T3 or 4, N0, M0) - Stage III disease (any T, N1 or 2, M0) - No rectal tumors - Distal extent of tumor ≥ 12 cm from the anal verge by endoscopy or surgical examination - T4 tumors involving an adjacent structure (e.g., bladder, small intestine, or ovary) by direct extension from the primary tumor are eligible provided the following criteria are met: - All or a portion of the adjacent structure was removed en bloc with the primary tumor - All grossly visible tumor was completely resected (i.e., curative resection) in the opinion of the surgeon - Margins of the resected specimen not involved with malignant cells by pathology - Not planning local radiotherapy - En bloc complete gross resection of tumor by open laparotomy or laparoscopically-assisted colectomy within the past 29-50 days - Two-stage surgical procedure allowed (i.e., decompressive colostomy followed by definitive surgical resection) - Patients with > 1 synchronous primary colon tumor are eligible - Disease staging based on more advanced primary tumor - No isolated, distant, or non-contiguous intra-abdominal metastases, even if resected PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Eastern Cooperative Oncology Group (ECOG) 0-1 Life expectancy - At least 5 years Hematopoietic - Absolute granulocyte count ≥ 1,500/mm^3 (unless it represents an ethnic or racial variation of normal) - Postoperative platelet count ≥ 100,000/mm^3 - No significant bleeding unrelated to the primary colon tumor within the past 6 months Hepatic - Bilirubin ≤ upper limit of normal (ULN) (unless due to slow conjugation of bilirubin caused by Gilbert's disease or a similar syndrome) - Alkaline phosphatase < 2.5 times ULN - Aspartate Aminotransferase (AST) < 1.5 times ULN - If AST > normal, serologic testing for hepatitis B and C is required and the results must be negative - No Prothrombin Time and International Normalized Ratio (PT/INR) > 1.5 unless patient is on full-dose anticoagulants AND the following criteria are met: - INR 2-3 on a stable dose of warfarin - No active bleeding - No pathological condition associated with a high risk of bleeding - No hepatic disease that would preclude study participation - No history of viral hepatitis or other chronic liver disease Renal - Serum creatinine ≤ 1.5 times ULN - Urine protein/creatinine ratio < 1.0 OR - < 1 g of protein on 24-hour urine collection - No renal disease that would preclude study participation Cardiovascular - No uncontrolled blood pressure, defined as > 150/90 mm Hg - No cardiovascular disease that would preclude study participation, including any of the following: - New York Heart Association class III or IV myocardial disease - Myocardial infarction within the past 12 months - Unstable angina within the past 12 months - Symptomatic arrhythmia - No history of transient ischemic attack or cerebrovascular accident - No arterial thrombotic event within the past 12 months - No symptomatic peripheral vascular disease Other - No other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum - Must be at low risk of recurrence from any prior malignancy - No serious or non-healing wound, skin ulcer, or bone fracture - No active gastroduodenal ulcer by endoscopy - No clinically significant peripheral neuropathy (i.e., neurosensory or neuromotor toxicity ≥ grade 2) - No significant traumatic injury within the past 4 weeks - No other nonmalignant systemic disease that would preclude study participation - No psychiatric or addictive disorder or other condition that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Patients randomized to receive bevacizumab must use effective contraception during and for 3 months after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent prophylactic growth factors - No concurrent biological response modifiers Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior radiotherapy for this malignancy - No concurrent radiotherapy for this malignancy Surgery - See Disease Characteristics - Recovered from prior surgery - More than 4 weeks since prior major surgery or open biopsy - More than 7 days since prior core biopsy or other minor surgery (except placement of a vascular access device) - No concurrent or anticipated concurrent major surgery Other - No prior systemic therapy for this malignancy - No concurrent halogenated antiviral agents (e.g., sorivudine) - No other concurrent investigational drugs - No other concurrent antineoplastic agents
Sponsor: National Cancer Institute (NCI)
Phase: Phase 3
Trial ID: NCT00096278
Not Accepting Healthy Volunteers