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

NCT00503035 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2023-02-13

Study results available
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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).

Conditions

Interventions

DRUG

Celecoxib

400 mg by mouth twice daily x 6 months

PROCEDURE

Colonoscopy Biopsy

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Imad Shureiqi, MD · M.D. Anderson Cancer Center

  • Robert S. Bresalier, MD · M.D. Anderson Cancer Center

  • Patrick Lynch, MD, JD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-20
Primary Completion
2021-04-02
Completion
2021-04-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00503035 on ClinicalTrials.gov