Celecoxib in Preventing Colorectal Cancer in Young Patients With a Genetic Predisposition for Familial Adenomatous Polyposis
- Conditions
- Colorectal CancerPrecancerous Condition
- Interventions
- Other: placebo
- Registration Number
- NCT00685568
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm I celecoxib Patients receive oral celecoxib twice daily for 3 months in the absence of disease progression or unacceptable toxicity. Arm II placebo Patients receive oral placebo twice daily for 3 months in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Toxicity 3 months
- Secondary Outcome Measures
Name Time Method Aberrant crypt foci (ACF) and adenoma burden in the entire colorectum 3 months Elimination of the learning curve in a phase II/III trial 3 months Comparison of sedation strategies based on local standards 3 months Validation of technique for scoring ACFs 3 months Short-term (3 month) impact of celecoxib on ACF count 3 months Adherence 3 months Influence of polymorphisms on age of onset of phenotype or on the number of colorectal polyps 3 months Feasibility of psychosocial questionnaires 3 months Pharmacokinetics (plasma drug trough concentrations) 3 months
Trial Locations
- Locations (4)
University of Texas Medical School at Houston
🇺🇸Houston, Texas, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States