NCT00331786

Nitric Oxide-Releasing Acetylsalicyclic Acid in Preventing Colorectal Cancer in Patients at High Risk of Colorectal Cancer

Phase I Multiple-Dose Safety, Pharmacokinetic and Pharmacodynamic Clinical Study of Nitric Oxide Releasing Aspirin (NCX 4016)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	nitric oxide-releasing acetylsalicylic acid derivative
OTHER	laboratory biomarker analysis
PROCEDURE	biopsy

Timeline

• Start date: 2006-07-01
• First posted: 2006-05-31
• Last updated: 2009-02-09

Locations

1 site across 1 country: United States