Phase II Study Of Colorectal ACF Screening, Regression And Prevention In High Risk Participants
- Determine the percentage change in colorectal aberrant crypt foci (ACF) in patients
with a history of colorectal cancer or at high risk for colorectal cancer when treated
with sulindac vs aspirin vs ursodiol.
- Determine the safety and efficacy of these drugs, in terms of ability to cause
regression of existing colorectal ACF and prevent new ACF development, in these
OUTLINE: This is a partially blinded, randomized, placebo-controlled study. Patients are
stratified according to colorectal neoplasia (adenoma vs carcinoma). Patients are randomized
to 1 of 4 treatment arms.
- Arm I: Patients receive oral sulindac twice daily.
- Arm II: Patients receive oral aspirin once daily.
- Arm III: Patients receive oral ursodiol three times daily.
- Arm IV: Patients receive oral sulindac placebo twice daily. In all arms, treatment
continues for 12 months in the absence of disease progression or unacceptable toxicity.
Patients undergo a colonoscopy at baseline and at the end of treatment.
Patients are followed at 2 months after the end of treatment.
PROJECTED ACCRUAL: A total of 172 patients (43 per treatment arm) with a history of
colorectal cancer or adenomas will be accrued for this study. A total of 20 additional
patients with no elevated risk of colorectal neoplasia will be accrued, but not randomized,
for this study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Percentage Change in Colorectal ACF Patients Treated with Sulindac, Aspirin or Ursodiol
Robert S. Bresalier, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|