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
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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