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Colorectal Cancer

Cetuximab and/or Bevacizumab + Combination Chemotherapy For Metastatic Colorectal Cancer (CTSU C80405)
A Phase III Trial of Irinotecan(Camptosar)/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin With Bevacizumab (Avastin), or Cetuximab (C225) (Erbitux), or With The Combination of Bevacizumab, or Cetuximab For Patients With Untreated Metastatic Adenocarcinoma of the Colon or Rectum
Status Conditions Phase Study ID
Closed Colon Cancer
Rectal Cancer
Colorectal Cancer
Phase III CTSU C80405
NCT00265850
Summary

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. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibodies together with combination chemotherapy may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with cetuximab and/or bevacizumab in treating patients with colorectal cancer.

PURPOSE: This randomized phase III trial is studying cetuximab and/or bevacizumab when given together with combination chemotherapy to compare how well they work in treating patients with metastatic colorectal cancer.


Investigator
Fred Appelbaum, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the colon or rectum

    • Locally advanced (unresectable) or metastatic disease

      • Patients with resected primary tumors who have documented metastases are eligible
      • Separate histological or cytological confirmation is not required from patients with a history of colorectal cancer (previously treated by surgical resection) who have now developed radiological or clinical evidence of metastatic disease, unless 1 of the following is true:

        • An interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease
        • The primary cancer was stage I
  • The intent of this treatment must be indicated as follows:

    • Palliative or neoadjuvant treatment with the potential for resection of all sites of metastatic disease
  • At least 1 paraffin block of previously resected primary tumor or tumor deposit available
  • Patients must have a wildtype K-ras gene
  • No known CNS metastases or carcinomatous meningitis
Last Updated
May 03, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.