Rectal Abberant Crypt Foci And Other Intermediate Biomarkers For Sporadic Colorectal Neoplasia: Cross-Sectional Prevelance And Modulation By Celecoxib
- Compare the effects of celecoxib vs placebo on the number of rectal aberrant crypt foci
in patients with premalignant rectal polyps or prior sporadic colorectal neoplasia.
- Compare the effects of these drugs on proliferation index, apoptotic index, and gene
expression patterns in ascending and descending colon tissue from these patients before
and after treatment.
- Assess gene expression patterns in normal mucosa from the ascending vs descending colon
in patients referred for screening, surveillance, or diagnostic colonoscopy.
OUTLINE: This is a randomized, double-blind, placebo-controlled, chemoprevention study.
Patients are stratified according to age (18 to 49 vs 50 and over) and number of rectal
aberrant crypt foci (5-9 vs 10 or more).
All patients undergo a baseline biomarker assessment and full colonoscopy to resect all
neoplasms, quantitate rectal aberrant crypt foci, and biopsy rectal mucosa.
Depending on the results of the biomarker assessments, patients are randomized to 1 of 2
treatment arms. Patients with no adenomas of 5 mm or greater receive no further treatment.
- Arm I: Patients receive oral celecoxib twice daily.
- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues
for 6 months in the absence of unacceptable toxicity.
All patients undergo an endoscopic exam of the colorectum at completion of study.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for the baseline biomarker
assessment and a total of 40 patients (20 per arm) will be accrued for the chemoprevention
study within 1 year.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
National Cancer Institute (NCI)
United States: Federal Government
|National Naval Medical Center||Bethesda, Maryland 20889|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|