Celecoxib in Preventing Colorectal Cancer in Young Patients With a Genetic Predisposition for Familial Adenomatous Polyposis
|ClinicalTrials.gov Identifier: NCT00685568|
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : November 20, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Precancerous Condition||Drug: celecoxib Other: placebo||Phase 1|
- Determine the safety and toxicity of celecoxib in pediatric patients with genotype-positive familial adenomatous polyposis.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Phase I Pilot Toxicity/Methods Validation Study of Celecoxib in Genotype-Positive Children With Familial Adenomatous Polyposis|
|Study Start Date :||December 2002|
|Primary Completion Date :||November 2006|
|Study Completion Date :||November 2006|
Experimental: Arm I
Patients receive oral celecoxib twice daily for 3 months in the absence of disease progression or unacceptable toxicity.
Orally, twice daily for 3 months; 50 mg tablets. Celecoxib escalating doses starting at 4 mg/kg/day.
Placebo Comparator: Arm II
Patients receive oral placebo twice daily for 3 months in the absence of disease progression or unacceptable toxicity.
Orally, twice daily for 3 months
- Toxicity [ Time Frame: 3 months ]
- Aberrant crypt foci (ACF) and adenoma burden in the entire colorectum [ Time Frame: 3 months ]
- Elimination of the learning curve in a phase II/III trial [ Time Frame: 3 months ]
- Comparison of sedation strategies based on local standards [ Time Frame: 3 months ]
- Validation of technique for scoring ACFs [ Time Frame: 3 months ]
- Short-term (3 month) impact of celecoxib on ACF count [ Time Frame: 3 months ]
- Adherence [ Time Frame: 3 months ]
- Influence of polymorphisms on age of onset of phenotype or on the number of colorectal polyps [ Time Frame: 3 months ]
- Feasibility of psychosocial questionnaires [ Time Frame: 3 months ]
- Pharmacokinetics (plasma drug trough concentrations) [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685568
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|University of Texas Medical School at Houston|
|Houston, Texas, United States, 77030|
|Study Chair:||Patrick M. Lynch, MD, JD||M.D. Anderson Cancer Center|