Molecular Targeting of 15-LOX-1 for Apoptosis Induction in Human Colorectal Cancers
Celecoxib is a drug that was developed to treat arthritis. However, celecoxib may also help
to stop or slow the growth of colon and rectal tumor cells.
At the start of the study, you will be asked questions about your medical history, have a
complete physical exam, and have around 2 tablespoons of blood drawn for blood tests as part
of your routine care for familial adenomatous polyposis. Also, blood tests such as fasting
blood glucose and lipid profiling (cholesterol, LDL, HDL and triglyceride) will be assessed
to determine eligibility. Women who are able to have children must have a negative blood
pregnancy test within 14 days of starting celecoxib.
Before your scheduled colonoscopy, you will fill out a form asking about any medications and
nutritional supplements that you are taking. In addition, you will be asked to complete a
diet history. This will help researchers to evaluate patients' dietary habits. The
questionnaire takes about 15 minutes to complete. You will also have around 1 teaspoon of
blood drawn to measure the amount of celecoxib in your blood. Then, during your already
scheduled colonoscopy procedure, you will have additional tissue biopsies (the size of a
pencil tip) of your colon taken. For a colonoscopy procedure, a flexible tube with a light
attached to the end is used to look inside your colon/lower gut. The biopsies will be taken
through the flexible tube using a special cutting tool. Up to 23 biopsy samples may be
taken. The biopsies should take about 20 extra minutes to complete.
After the procedure, you will start taking celecoxib by mouth once every 12 hours for 6
months. You will also have around 1 teaspoon of blood drawn to measure the amount of
celecoxib in your blood at the completion of month 2 and 4 of celecoxib treatment. At the
end of the 6 month treatment period, you will have another colonoscopy procedure. This is
an additional procedure performed solely for this study and is not part of your standard of
care for the treatment of familial adenomatous polyposis. A second set of biopsies will be
taken (23 maximum). These biopsy samples will be studied and compared to the samples taken
before treatment with celecoxib. You will also have around 1 teaspoon of blood drawn to
measure the amount of celecoxib in your blood.
You will be contacted by phone 72 hours after your first dose of celecoxib and then every 2
weeks for the study to check for any side effects you may be experiencing.
The maximum amount of time you will remain on this study is 6 months. If at any time, you
experience any intolerable side effects, you will be taken off the study.
This is an investigational study. Celecoxib is FDA approved and commercially available for
familial adenomatous polyposis patients to reduce polyp formation. Up to 40 patients will
take part in this study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
13-S-HODE, 15-LOX-1 primary product, levels (measured by ELISA assay)
GATA-6 and 15-LOX-1 expression, 13-S-HODE levels, and apoptosis rates in normal and colorectal polyp epithelial tissues before and after 6 months of celecoxib treatment of patients with familial adenomatous polyposis (FAP).
Baseline to post 6 months of celecoxib treatment
Imad Shureiqi, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|