Related Links Educational Materials About Clinical Trials Clinical Trials: Questions and Answers Questions to Ask Your Doctor Drug Information from MedlinePlus

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Phase III Randomized Study of Oxaliplatin, Leucovorin Calcium, and Fluorouracil With Versus Without Bevacizumab in Patients With Resected Stage II Colon Cancer and at High Risk for Recurrence Based on Molecular Markers

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Temporarily closed	18 and over	NCI	ECOG-E5202 E5202, NCT00217737

Special Category: CTSU trial, NCI - CMS pilot project trial, NCI Web site featured trial

Trial Description

Purpose:

Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as 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. Giving combination chemotherapy together with bevacizumab after surgery may kill any remaining tumor cells or prevent the cancer from coming back. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone or observation only in treating colon cancer.

This randomized phase III trial is studying oxaliplatin, leucovorin, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin, and fluorouracil or observation only in treating patients who have undergone surgery for stage II colon cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Has undergone surgery to remove the tumor between the past 1-2 months
• No previous radiation therapy for this cancer
• More than 4 weeks since surgery or open biopsy
• No previous systemic therapy for this cancer
• 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.

Treatment/Intervention:

Some patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups. Other patients will be assigned to group three.

Patients in group one will receive a 2-hour infusion of oxaliplatin and a 2-hour infusion of leucovorin once in week 1. They will also receive a 2-day continuous infusion of fluorouracil in week 1. Treatment may repeat every 2 weeks for up to 12 courses.

Patients in group two will receive a 2-hour infusion of oxaliplatin and a 2-hour infusion of leucovorin once in week 1. They will also receive a 2-day continuous infusion of fluorouracil and a 30- to 90-minute infusion of bevacizumab once in week 1. Treatment may repeat every 2 weeks for up to 12 courses. Patients will then receive bevacizumab alone for up to 12 additional courses.

Patients in group three will undergo observation only.

Patients will be evaluated every 3 months for 1-2 years, every 6 months for 3 years, and once a year for up to 10 years from study entry.

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 Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Al Benson, MD, FACP, Protocol chair		Ph: 312-695-6180
Peter O'Dwyer, MD, BCh, Protocol co-chair		Ph: 215-662-7606 Email: peter.odwyer@uphs.upenn.edu

Related Information

Featured trial article

Registry Information
Official Title		A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers
Trial Start Date		2005-08-04
Trial Completion Date		2011-04-17 (estimated)
Registered in ClinicalTrials.gov		NCT00217737
Date Submitted to PDQ		2005-08-02
Information Last Verified		2009-04-30
NCI Grant/Contract Number		CA21115