Alternate Title
Basic Trial Information
Trial Description
Purpose
Eligibility
Treatment/Intervention
Trial Contact Information
Related Information
Registry Information
Phase III Randomized Study of Cetuximab and/or Bevacizumab in Combination With Either Oxaliplatin, Fluorouracil, and Leucovorin Calcium (FOLFOX) OR Irinotecan Hydrochloride, Fluorouracil, and Leucovorin Calcium (FOLFIRI) in Patients With Previously Untreated Metastatic Adenocarcinoma of the Colon or Rectum (Arm III [Cetuximab and Bevacizumab in Combination With FOLFOX or FOLFIRI] Closed to Accrual as of 09/10/2009)
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Closed | 18 and over | NCI | CALGB-C80405 C80405, SWOG-C80405, NCT00265850 |
Special Category: NCI Web site featured trial, NCI - CMS pilot project trial, CTSU trial
Trial Description
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.
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.
Eligibility criteria include the following:
- At least 18 years old
- No CNS metastases
- No previous bevacizumab or cetuximab
- At least 4 weeks since radiation therapy or surgery
- For more information about the eligibility criteria for this trial, refer to the Health Professional version.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Patients will be randomly assigned (have an equal chance of being placed) to one of three treatment groups. (Group three closed to enrollment as of 09/10/2009)
Patients in group one will receive a 2-hour infusion of oxaliplatin or a 30- to 90-minute infusion of irinotecan; a 2-hour infusion of leucovorin; a 2-day continuous infusion of fluorouracil; and a 30- to 90-minute infusion of bevacizumab in weeks 1, 3, 5, and 7. Treatment may repeat every 8 weeks for at least two courses.
Patients in group two will receive a 2-hour infusion of oxaliplatin or a 30- to 90-minute infusion of irinotecan; a 2-hour infusion of leucovorin; and a 2-day continuous infusion of fluorouracil in weeks 1, 3, 5, and 7. They will also receive a 1- to 2-hour infusion of cetuximab once a week for 8 weeks. Treatment may repeat every 8 weeks for at least two courses.
Patients in group three will receive a 2-hour infusion of oxaliplatin or a 30- to 90-minute infusion of irinotecan; a 2-hour infusion of leucovorin; a 2-day continuous infusion of fluorouracil; and a 30- to 90-minute infusion of bevacizumab in weeks 1, 3, 5, and 7. They will also receive a 1- to 2-hour infusion of cetuximab once a week for 8 weeks. Treatment may repeat every 8 weeks for at least two courses. (Group three closed to enrollment as of 09/10/2009)
After finishing treatment, patients will be evaluated every 2 months for 5 years and every 6 months for 5 years.
Important:
For more details about this trial, refer to the Health Professional version of the trial summary.
If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.
Trial Lead Organizations
Cancer and Leukemia Group B
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| Alan Venook, MD, Protocol chair | |
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Southwest Oncology Group
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| Charles Blanke, MD, FACP, Protocol chair | |
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Related Information
| Registry Information | ||
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| Official Title | A Phase III Trial of Irinotecan / 5-FU / Leucovorin or Oxaliplatin / 5-FU/ Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum | |
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| Trial Start Date | 2005-11-30 | |
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| Trial Completion Date | 2013-03-31 (estimated) | |
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| Registered in ClinicalTrials.gov | NCT00265850 | |
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| Date Submitted to PDQ | 2005-11-04 | |
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| Information Last Verified | 2012-03-02 | |
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| NCI Grant/Contract Number | CA37447 | |
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