Phase I Pilot Toxicity/Methods Validation Study of Celecoxib in Genotype-Positive Children With Familial Adenomatous Polyposis
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Toxicity
3 months
Yes
Patrick M. Lynch, MD, JD
Study Chair
M.D. Anderson Cancer Center
United States: Institutional Review Board
ID02-090
NCT00685568
December 2002
November 2006
Name | Location |
---|---|
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Texas Children's Hospital | Houston, Texas |
University of Texas Medical School at Houston | Houston, Texas 77030 |