Nitric Oxide-Releasing Acetylsalicyclic Acid in Preventing Colorectal Cancer in Patients at High Risk of Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00331786
- Lead Sponsor
- Stony Brook University
- Brief Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of nitric oxide-releasing acetylsalicyclic acid may prevent colorectal cancer.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of nitric oxide-releasing acetylsalicyclic acid in preventing colorectal cancer in patients at high risk of colorectal cancer.
- Detailed Description
OBJECTIVES:
Primary
* Evaluate the effects of nitric oxide-releasing acetylsalicyclic acid on aberrant cryptic foci (ACF) in patients at high risk for colon cancer.
Secondary
* Determine the pharmacokinetic profile of this drug in these patients.
* Determine the presence or absence of ACF in these patients.
* Determine the expression of PGE2, COX-1, COX-2, NF-kB, and β-catenin in colon tissue.
* Determine the safety and tolerability of long-term nitric oxide-releasing acetylsalicyclic acid in these patients.
OUTLINE: This is a multicenter, double-blind, randomized, placebo-controlled, parallel group study. Patients are stratified according to gender and race (black vs non-Hispanic white vs Hispanic white vs Asian). Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive oral nitric oxide-releasing acetylsalicyclic acid twice daily for 6 months.
* Arm II: Patients receive nitric oxide-releasing acetylsalicyclic acid twice daily for 6 months at a higher dose than in arm I.
* Arm III: Patients receive oral placebo twice daily for 6 months. Patients undergo sigmoidoscopies at baseline and at the completion of study treatment. Biopsies of aberrant cryptic foci (ACF) and non-ACF sites are collected at both sigmoidoscopies. Tissue is examined for biomarkers (PGE_2, COX, NF-kB, β-catenin).
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effects of nitric oxide-releasing acetylsalicyclic acid (NCX 4016) on aberrant cryptic foci (ACF) multiplicity after the second dose at 6 months
- Secondary Outcome Measures
Name Time Method Pharmacokinetic profile by blood, urine, and colon tissue sampling Incidence of ACF as measured by magnification chromoendoscopy Data on C-Reactive protein as a marker for inflammation Assessment of biomarkers expressed in colon tissue, including PGE2 (measured by immunoassay), COX-1, COX-2, NF-kB, and β-catenin (measured by immunohistochemistry) at baseline and at the final visit Safety and tolerability of long-term oral administration of NCX 4016 as measured by NCI CTCAE v3.0
Trial Locations
- Locations (1)
Stony Brook University Cancer Center
🇺🇸Stony Brook, New York, United States