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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin Versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients With Stage II Colon Cancer at High Risk for Recurrence to Deter

Brief Summary: This randomized phase III trial studies oxaliplatin, leucovorin calcium, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin calcium, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, 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.

Detailed Summary:

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 (leucovorin calcium), 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 calcium 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 calcium, 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 und
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Disease-free survival [ Time Frame: Up to 10 years ]

Original Primary Outcome:

Current Secondary Outcome:

  • Impact of tumor biologic characteristics and their relationship to overall survival [ Time Frame: Up to 10 years ]
    Analysis of tumor biological characteristics and their relationship to overall survival will be conducted between high and low risk populations.
  • Incidence of adverse events graded by NCI CTCAE 4.0 [ Time Frame: Up to 10 years ]
    We will tabulate and report adverse events by treatment arm and note those events that differ statistically between arms. No formal type I error adjustment will be done for the toxicity analyses.
  • Overall survival [ Time Frame: Up to 10 years ]


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: September 20, 2005
Date Started: August 2005
Date Completion:
Last Updated: December 30, 2016
Last Verified: December 2016