Banning Genetic Discrimination
By: Sherri Patterson
Coordinator, Chemoprevention Program

The sponsor for this study is the National Cancer Institute. The trial will be conducted primarily at M. D. Anderson although other sites may be added. We will be enrolling 56 patients within the next 9 months from across the United States. Since FAP is an inherited condition, we will allow more than one member from a family to enroll. All participants must meet certain inclusion and exclusion criteria. Potential participants must be able to answer "yes" to the following

• Age >18 with a confirmed diagnosis of FAP (either by family history and polyp burden or by genetic testing)
• Have an endoscopically assessable colon or rectal segment containing at least five polyps
• Willing to abstain from using non-steroidal anti-inflammatory drugs, including aspirin, for several months before starting the study and for the entire time on the trial
• If a woman of childbearing potential, willing to use adequate contraception and undergo a serum pregnancy test
• Able to return for follow-up tests
• Willing to sign informed consent.

Potential participants must be able to answer "no" to the following:

• Anticipate colectomy within the next 8 to 12 months or have had a colectomy within the last 12 months
• Have a history of any of the following:
  • hypersensitivity to COX-2 inhibitors, sulfonamides, non-steroidal anti-inflammatory drugs, or salicylates
  • irradiation of the pelvis
  • gastric or duodenal ulcers except those caused by Helicobactor pylori.
  • invasive carcinoma in the past 5 years other than resected Duke's A/B1 colon cancer or resected non-melanomatous skin cancer