Familial Adenomatous Polyposis
CHIP: Children’s International Polyposis Trial
A phase III placebo-controlled trial of celecoxib in genotype-positive subjects with familial adenomatous polyposis
Primary Investigator
Stephen B. Gruber, MD, PhD, MPH
Co-investigators
D. Kim Turgeon, MD
N. Jewel Samadder, MD
Study Coordinator
Victoria Raymond, e-mail: vraymond@umich.edu or telephone: (734) 647-0822
Study Description
Familial adenomatous polyposis (FAP) is a rare genetic condition that predisposes patients to develop hundreds to thousands of potentially precancerous polyps (adenomas) in the colon and rectum, usually beginning in adolescence. The standard of care has long been considered to be prophylactic colectomy with ileorectal anastomosis or ileo–pouch anastomosis at diagnosis. The least invasive method for maintaining a minimal polyp burden is through colonoscopic polypectomy. However, polypectomy is effective only for a short period of time in patients with FAP due to the continuous development of new polyps in large numbers. The addition of a drug that can stabilize or regress adenomas and that would maintain the polyp burden within the realm of endoscopic management could potentially delay or even prevent the need for surgery and would be of substantial benefit to patients with FAP. The potential for celecoxib in cancer prevention was first confirmed clinically in patients with FAP in whom celecoxib 400 mg twice a day was effective in reducing the number of intestinal polyps.
The pediatric FAP phase III protocol is designed to compare efficacy of celecoxib versus placebo in polyp prevention over a 5-year treatment period in subjects between the ages of 10 to 17 years inclusive with a confirmed diagnosis of FAP based on genetic predisposition testing.
Subject Eligibility
- Children between the ages of 10 to 17 years inclusive with a confirmed diagnosis of FAP based on genetic testing
- Intact colon
- Have <20 colorectal polyps visible (>2 mm) and be able to be rendered polyp free at baseline colonoscopy
Trial Design
Approximately 200 eligible subjects with FAP from multiple international centers will be randomized in a 1:1 ratio to receive either celecoxib or matching placebo for up to 5 years.
Requirements
Annual colonoscopy and polypectomy at the University of Michigan. Annual physical examination and blood work at the University of Michigan. Monitoring phone calls every 3 months.
