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

Alternate Title

Phase III Randomized Study of Celecoxib for Prevention of Capecitabine-Induced Palmar/Plantar Syndrome in Patients With Metastatic Breast or Colorectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care, Treatment Completed 18 and over NCI MDA-CCC-0326 MDA-2005-0328, NCT00305643

Trial Description

Purpose:

Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with capecitabine may kill more tumor cells. Celecoxib may prevent or lessen hand-foot syndrome caused by capecitabine.

This randomized phase III trial is studying how well celecoxib works in preventing hand/foot syndrome caused by capecitabine in patients with metastatic breast or colorectal cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Planning to receive treatment with capecitabine
• 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 undergo radiation therapy 5 days a week for 5-6 weeks. At the same time, they will receive capecitabine by mouth twice a day 5 days a week. After finishing radiation therapy, patients may continue to receive capecitabine by mouth once a day for 2 weeks. Treatment with capecitabine may repeat every 3 weeks.

Other patients will receive capecitabine by mouth once a day for 2 weeks. Treatment may repeat every 3 weeks.

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

Patients in group one will receive celecoxib by mouth twice a day for as long as benefit is shown.

Patients in group two will receive a placebo by mouth twice a day for as long as benefit is shown.

After finishing treatment, patients will be evaluated every 3 months.

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

University of Texas M.D. Anderson CCOP Research Base

E. Scott Kopetz, MD, Principal investigator		Ph: 713-792-2828; 800-392-1611

Registry Information
Official Title		A Multicenter Phase III Placebo-Controlled Trial of Celecoxib for Prevention of Capecitabine-Induced Palmar/Plantar (Hand/Foot) Syndrome in Patients with Metastatic Breast and Colorectal Cancer
Trial Start Date		2006-01-25
Trial Completion Date		2008-10-01
Registered in ClinicalTrials.gov		NCT00305643
Date Submitted to PDQ		2005-11-30
Information Last Verified		2008-10-15
NCI Grant/Contract Number		CA16672