Name of the Trial
Phase II Randomized Study of Celecoxib with or without Eflornithine for the Prevention of Colorectal Cancer in Participants with Familiar Adenomatous Polyposis of the Colorectum (MDA-ID-00109). See the protocol summary at http://cancer.gov/clinicaltrials/MDA-ID-00109.

Principal Investigator
Dr. Patrick Lynch of the University of Texas M. D. Anderson Cancer Center

Why Is This Trial Important?
Cancers of the colon and rectum are the fourth most commonly diagnosed cancers and rank second among the causes of cancer death in the United States. An inherited condition called familial adenomatous polyposis (FAP) increases the risk of colon cancer. FAP is characterized by numerous polyps (protruding growths) forming on the inside walls of the colon and rectum. Most people diagnosed with FAP undergo colectomy - surgical removal of all or part of the colon.

Researchers are interested in developing drugs that may offer an additional measure of protection to patients with FAP who either have or have not yet had a colectomy. In this study, researchers are trying to determine if the use of the drugs celecoxib and eflornithine may be an effective way to prevent colorectal cancer in patients who have FAP.

"What makes this study different is that we are pursuing a combination treatment that builds on previous studies of nonselective as well as selective COX-2 inhibitors," said Dr. Lynch. "Those previous studies have shown mixed responses in terms of efficacy from individual drugs, with response rates averaging around 30 percent. With this combination therapy, we hope to achieve synergy and, consequently, to effect a greater reduction in polyp burden than with a single agent alone."

Who Can Join This Trial?
Researchers seek to enroll 120 patients between the ages of 18 and 65 who have been diagnosed with FAP. See the full list of eligibility criteria for this trial at http://cancer.gov/clinicaltrials/MDA-ID-00109.

Where Is This Trial Taking Place?
Study sites in the United States and England are enrolling patients in this trial. See the list of study sites at http://cancer.gov/clinicaltrials/MDA-ID-00109.

Who to Contact
See the list of study contacts at http://cancer.gov/clinicaltrials/MDA-ID-00109 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.

An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.