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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00096278
Phase
PHASE3
Status
Completed

Conditions

  • Colon Adenocarcinoma
  • Stage IIA Colon Cancer AJCC v7
  • Stage IIB Colon Cancer AJCC v7
  • Stage IIC Colon Cancer AJCC v7
  • Stage IIIA Colon Cancer AJCC v7
  • Stage IIIB Colon Cancer AJCC v7
  • Stage IIIC Colon Cancer AJCC v7

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Fluorouracil — DRUG
    Given IV
  • Leucovorin Calcium — DRUG
    Given IV
  • Oxaliplatin — DRUG
    Given IV

Study Details

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. 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.

Key Dates

First listed
Nov 9, 2004
Start date
Sep 15, 2004
Status verified
Jul 2019
Primary completion
Mar 12, 2009
Completion
Dec 31, 2012

Study Design

Enrollment
2,710 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I (mFOLFOX6)
    Patients receive adjuvant chemotherapy comprising concurrent oxaliplatin and leucovorin calcium IV over 2 hours on day 1. Patients also receive adjuvant fluorouracil IV over 2-4 minutes on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (bevacizumab, mFOLFOX6)
    Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive adjuvant oxaliplatin, leucovorin calcium, and fluorouracil as in arm I. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of adjuvant chemotherapy, patients continue to receive bevacizumab alone every 14 days for 6 months in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Disease-free Survival [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Surgical Adjuvant Breast and Bowel ProjectPittsburghPennsylvania15212-5234-

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