Cetuximab, Leucovorin, Oxaliplatin, and Fluorouracil With or Without Bevacizumab in Treating Patients With Resectable Liver Metastases From Colorectal Cancer

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT00438737
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
  • cetuximab — BIOLOGICAL
  • fluorouracil — DRUG
  • leucovorin calcium — DRUG
  • oxaliplatin — DRUG
  • adjuvant therapy — PROCEDURE
  • conventional surgery — PROCEDURE
  • neoadjuvant therapy — PROCEDURE

Study Details

RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.Drugs used in chemotherapy, such as leucovorin, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy and bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized phase II trial is studying the side effects and how well giving cetuximab together with leucovorin, oxaliplatin, and fluorouracil works with or without bevacizumab in treating patients with resectable liver metastases from colorectal cancer.

Key Dates

First listed
Feb 22, 2007
Start date
Jan 31, 2007
Status verified
Sep 2007

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Primary purpose
TREATMENT

Primary Outcome Measure

Response rate (preoperative response rate)

Related Studies