CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Celecoxib +1 moredrug
Likely dose
Celecoxib 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00503035
NCT00503035Phase 2Completed
CompareCT.gov

Molecular Targeting of 15-LOX-1 for Apoptosis Induction in Human Colorectal Cancers

M.D. Anderson Cancer Center·interventional·Posted Jul 18, 2007·Updated Feb 13, 2023

In Brief

A Phase 2 clinical trial evaluating Celecoxib and Colonoscopy Biopsy for Familial Adenomatous Polyposis. Completed, enrolled 51 participants across 1 site.

Detailed Summary

Primary Objective: * To determine whether celecoxib downregulates GATA-6 expression to upregulate 15-LOX-1 expression and induce apoptosis in human rectal tumors, researchers will measure GATA-6 and 15-LOX-1 expression, 13-S-HODE levels, and apoptosis rates in normal and colorectal polyp epithelial tissues before and after 6 months of celecoxib treatment of patients with familial adenomatous polyposis (FAP).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFamilial Adenomatous Polyposis
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 18, 2007
Enrollment StartAug 20, 2003
Primary CompletionApr 2, 2021
TodayJul 2, 2026
Enrollment to primary: 17.6 yearsPosted 19.0 years ago

Interventions

Celecoxibdrug

400 mg by mouth twice daily x 6 months

Colonoscopy Biopsyprocedure

Up to 23 additional colon tissue biopsies (the size of a pencil tip), additional 20 minutes on colonoscopy procedure