Are you willing to be a research participant?
A study sponsored by the National Cancer Institute for adults with FAP

St. Mark's is part of a multi-centre trial investigating medications to prolong the life of your rectum and duodenum.

Through participation in this study, you will help researchers understand whether new drugs may play a role in reducing the type and number of cellular changes that lead to the occurrence of colonic polyps and cancer. This study is supported by a research contract from the National Cancer Institute in America. Study medications are provided by Pfizer and Ilex Oncology.

Frequently Asked Questions

  • What is the goal of this study?
    We know that cancer involves many changes in the cells that line the colon. Many of these changes occur before a polyp or cancer begins to grow. This study will examine whether the study drugs affect these changes.

  • What are the drugs being studied?
    Celecoxib (Celebrex™) has been approved by the FDA in America for reducing polyp formation in people with familial adenomatous polyposis (FAP). DFMO (Elfornithineä) inhibits an enzyme that is elevated in many tumors and pre-malignant conditions. DFMO may cause subtle changes in hearing (which are usually reversible). Therefore all participants will undergo hearing tests during the course of the study.

  • Are there side effects?
    Separately, the study drugs have been associated with few side effects at similar doses in studies of patients with other conditions. This is the first study in which the drugs will be combined. If side effects occur, appropriate medical intervention will be provided.

  • How will this be studied?
    The Investigators will compare groups of people taking just Celebrex to those taking Celebrex plus DFMO. Drug group assignments will not be known to you or to your doctor, making this a "double-blind" study.

  • How long will I participate?
    You will be asked to participate in this trial for six months.

  • What do I have to do to participate?
    Clinic visits will be scheduled for a hearing, blood and urine tests, as well as examinations and biopsies of the colon/rectum (large intestine) and stomach and duodenum (a segment of the small intestine) at the beginning and end of the study. After three months on study, the hearing, blood and urine tests will be repeated. At the end of the study, we will repeat the same tests that were done at the beginning of the study. During the study, we will also be collecting information regarding your general health via the telephone.

  • Will I incur any study costs?
    Reasonable travel and lodging expenses for those who reside outside the clinical centre area will be reimbursed.

  • Must I change my diet or other health habits?
    No changes in your diet or other habits are required to participate. You will be asked not to take your own aspirin or other anti-inflammatory medicines while participating in the trial. Acetaminophen will be provided to you for any conditions requiring pain relief during this time.

You may participate if you …

  • Have a confirmed diagnosis of FAP
  • Have at least your rectum remaining
  • Have at least five small polyps in your colon and/or rectum
  • Are willing to undergo a sigmoidoscopy and gastroscopy initially and at the end of the study
  • Agree to take the study drug(s) as instructed

You may not be able to participate if you …

  • Have had all of your colon and rectum removed
  • Have too few polyps in your colon and/or rectum
  • Have experienced hearing loss
  • Do not have a definitive diagnosis of FAP
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The funds of the Polyposis Registry at St Mark's are administered by The St Mark's Hospital Foundation (Registered charity number 1088119)
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