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

NCT00096278 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2710

Last updated 2019-07-30

Study results available
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Summary

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.

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

Interventions

BIOLOGICAL

Bevacizumab

Given IV

DRUG

Fluorouracil

Given IV

DRUG

Leucovorin Calcium

Given IV

DRUG

Oxaliplatin

Given IV

Sponsors & Collaborators

  • NSABP Foundation Inc

    collaborator NETWORK

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Carmen J Allegra · NSABP Foundation Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-15
Primary Completion
2009-03-12
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00096278 on ClinicalTrials.gov