This randomized phase III trial studies oxaliplatin, leucovorin, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer.
PRIMARY OBJECTIVES: I. To demonstrate an improvement in 3-year disease-free survival for high-risk stage II colon cancer patients randomly assigned to 5-FU (fluorouracil), leucovorin, oxaliplatin versus 5-FU, leucovorin, oxaliplatin and bevacizumab. SECONDARY OBJECTIVES: I. To compare overall survival between the regimens. II. To further define the toxicity profiles of the regimens. III. To prospectively determine the impact of tumor biological characteristics on the survival of patients with stage II colon cancer. IV. To assess the association between oxaliplatin exposure, allelic variants in candidate genes, and neurotoxicity. (Pharmacogenetic ancillary objective) OUTLINE: Patients with high-risk disease are randomized to 1 of 2 treatment arms (Arms A and B). Patients with low-risk disease are assigned to Arm C. ARM A: Patients receive oxaliplatin intravenously (IV) over 2 hours and leucovorin IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive oxaliplatin, leucovorin, and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses in the absence of disease progression or unacceptable toxicity. ARM C: Patients undergo observation. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months for 10 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,431
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Clearview Cancer Institute
Huntsville, Alabama, United States
Mobile Infirmary Medical Center
Mobile, Alabama, United States
Providence Hospital
Mobile, Alabama, United States
Disease-free Survival Rate at 5 Years
Disease-free survival (DFS) is defined as the time from randomization to the earlier of disease recurrence, new invasive primary cancer, or death from any cause. The Kaplan-Meier estimates were used to characterize the 5-year DFS rates.
Time frame: Assessed every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization
Overall Survival Rate at 5 Years
Overall survival (OS) is defined as the time from randomization to death from any cause. OS is censored at the date of last contact for patients still alive. The Kaplan-Meier estimates were used to characterize the 5-year OS rates.
Time frame: Assessed every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization
The Impact of Tumor Biological Characteristics on Overall Survival
Overall survival (OS) is defined as the time from randomization to death from any cause. OS is censored at the date of last contact for patients still alive. The following patient/tumor characteristics were associated with overall survival: * ECOG Performance Status (0, 1, or 2) * Age * Sex (male, female) * Primary tumor site (right-side colon, transverse colon, left-side colon, or other) * Number of regional lymph nodes Hazard ratios with adjustment for other covariates are reported with OS as the outcome variable.
Time frame: Assessed at baseline, every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization
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