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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 Adjuvant Therapy Comprising Oxaliplatin and Capecitabine With Versus Without Hepatic Arterial Infusion of Floxuridine in Patients Undergoing Surgical Resection and/or Ablation for Hepatic Metastases From Colorectal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	18 and over	NCI	NSABP-C-09 NCT00268463

Special Category: NCI Web site featured trial, CTSU trial

Trial Description

Purpose:

Drugs used in chemotherapy, such as oxaliplatin, capecitabine, and floxuridine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hepatic arterial infusion uses a catheter to carry tumor-killing substances, such as chemotherapy, directly into the liver. Giving chemotherapy in different ways may kill more tumor cells. It is not yet known whether giving oxaliplatin and capecitabine together with an hepatic arterial infusion with floxuridine is more effective than giving oxaliplatin and capecitabine alone in treating patients who are undergoing surgery and/or ablation for liver metastases due to colorectal cancer.

This randomized phase III trial is studying oxaliplatin, capecitabine, and an hepatic arterial infusion with floxuridine to see how well they work compared to oxaliplatin and capecitabine in treating patients who are undergoing surgery and/or ablation for liver metastases due to colorectal cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No metastases outside of the liver
• No previous colorectal metastases
• More than 6 months since fluorouracil, levamisole, leucovorin, irinotecan, or oxaliplatin
• No previous hepatic arterial infusion therapy
• No previous radiation therapy to the liver
• 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:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

All patients will undergo surgery and/or ablation to remove up to six of the liver metastases.

Within 4 to 6 weeks after surgery and/or ablation, patients in group one will receive a 2-hour infusion of oxaliplatin once in week 1. They will also receive capecitabine by mouth twice a day for 2 weeks. Treatment may repeat every 3 weeks for up to eight courses.

Within 4 to 6 weeks after surgery and/or ablation, patients in group two will receive a 2-week continuous infusion of floxuridine directly into the arteries around the liver tumor. They will also receive a 2-hour infusion of oxaliplatin once in week 4 and capecitabine by mouth twice a day in weeks 4 and 5. Treatment may repeat every 6 weeks for up to four courses. Patients will then receive a 2-hour infusion of oxaliplatin once in week 1. They will also receive capecitabine by mouth twice a day for 2 weeks. Treatment may repeat every 3 weeks for up to four courses.

Quality of life will be assessed periodically. After finishing treatment, patients will be evaluated periodically.

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

National Surgical Adjuvant Breast and Bowel Project

Lawrence Wagman, MD, Protocol chair		Ph: 626-359-8111 Email: becomingapatient@coh.org

Related Information

Featured trial article

Registry Information
Official Title		A Phase III Clinical Trial Comparing Oxaliplatin, Capecitabine and Hepatic Arterial Infusion of Floxuridine to Oxaliplatin and Capecitabine in Patients with Resected or Ablated Liver Metastases from Colorectal Cancer
Trial Start Date		2006-01-13
Trial Completion Date		2008-06-12
Registered in ClinicalTrials.gov		NCT00268463
Date Submitted to PDQ		2005-10-12
Information Last Verified		2008-10-27

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