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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