Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-01-03 @ 5:57 PM
Study NCT ID:
NCT00685568
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2008-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celecoxib in Preventing Colorectal Cancer in Young Patients With a Genetic Predisposition for Familial Adenomatous Polyposis
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase I Pilot Toxicity/Methods Validation Study of Celecoxib in Genotype-Positive Children With Familial Adenomatous Polyposis
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: