Protocol
10-176
Full Title
A Phase III Placebo-Controlled Trial of Celecoxib in Genotype Positive Subjects with Familial Adenomatous
Purpose
Familial adenomatous polyposis (FAP) is a genetic condition which causes the growth of many small growths in the colon, especially as people with FAP get older. These polyps do not start out to be cancerous, but as they grow they often develop into cancer.
The purpose of this study is to determine if giving the drug celecoxib (Celebrex) to children and adolescents with FAP can keep the number and size of polyps to a level that would delay or even prevent the need for a colectomy (surgical removal of part of the bowel). Another goal of the study is to see if celecoxib can be used safely in children with the genetic mutation that causes FAP when taken over a period of five years.
Participants in this study will receive celecoxib or a placebo.
Investigator
Eligibility
To be eligible for this study, participants must meet several criteria, including but not limited to the following:
- Participants must be genetically positive for non-attenuated FAP and be between the ages of 10 and 17 (inclusive).
- Participants may not use non-steroidal anti-inflammatory agents (NSAIDs) chronically (7 consecutive days for more than 3 weeks per year) for the duration of the study.
- Participants may not have 20 or more polyps at baseline colonoscopy. All polyps found must be removed during baseline colonoscopy.
- Participants may not have diabetes or clinically significant ECG abnormalities.
For more information about this study, please contact Dr. Jose Guillem at 212-639-8278.
Disease(s)
Colorectal Cancer
Colorectal Cancer: Colon Cancer
Locations
Related Diseases
