NCT00685568

Celecoxib in Preventing Colorectal Cancer in Young Patients With a Genetic Predisposition for Familial Adenomatous Polyposis

Phase I Pilot Toxicity/Methods Validation Study of Celecoxib in Genotype-Positive Children With Familial Adenomatous Polyposis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 10 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of celecoxib may keep polyps and colorectal cancer from forming in patients with familial adenomatous polyposis. PURPOSE: This randomized phase I trial is studying the side effects and best dose of celecoxib in treating young patients with a genetic predisposition for familial adenomatous polyposis.

Detailed description

OBJECTIVES: Primary * Determine the safety and toxicity of celecoxib in pediatric patients with genotype-positive familial adenomatous polyposis. Secondary * Determine the aberrant crypt foci (ACF) and adenoma burden in the entire colorectum of these patients. * Eliminate the learning curve in a phase II/III trial (reproducibility of endoscopic techniques, tolerability of procedure). * Compare sedation strategies based on local standards (monitored anesthesia care vs conscious sedation). * Validate the ACF scoring technique. * Establish the short-term (3 month) impact of celecoxib on ACF count in order to determine appropriateness of ACF as a pathologic endpoint in a phase II/III trial. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral celecoxib twice daily for 3 months in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive oral placebo twice daily for 3 months in the absence of disease progression or unacceptable toxicity. Patients undergo colonoscopy at baseline and at 3 months. Patients also complete psychosocial questionnaires at baseline. Blood samples are collected at baseline to assess the influence of polymorphisms (CYP2C9, uridine diphosphate (UDP)-glucuronosyl transferase, A6, glutathione S-transferase \[GST\] M1, and Glutathione S-transferase (GST) theta 1 (GSTT1)) on age of onset of phenotype or number of colorectal polyps. Plasma drug trough levels are assessed at baseline, 1 month, and 3 months. After completion of study treatment, patients are followed periodically for up to 2 months.

Conditions

• Colorectal Cancer
• Precancerous Condition

Interventions

Type	Name	Description
DRUG	celecoxib	Orally, twice daily for 3 months; 50 mg tablets. Celecoxib escalating doses starting at 4 mg/kg/day.
OTHER	placebo	Orally, twice daily for 3 months

Timeline

• Start date: 2002-11-21
• Primary completion: 2006-04-21
• Completion: 2006-04-21
• First posted: 2008-05-28
• Last updated: 2018-11-07

Locations

4 sites across 1 country: United States