Nitric Oxide-Releasing Acetylsalicyclic Acid in Preventing Colorectal Cancer in Patients at High Risk of Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00331786|
Recruitment Status : Completed
First Posted : May 31, 2006
Last Update Posted : February 9, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: nitric oxide-releasing acetylsalicylic acid derivative Other: laboratory biomarker analysis Procedure: biopsy||Phase 1|
- Evaluate the effects of nitric oxide-releasing acetylsalicyclic acid on aberrant cryptic foci (ACF) in patients at high risk for colon cancer.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Official Title:||Phase I Multiple-Dose Safety, Pharmacokinetic and Pharmacodynamic Clinical Study of Nitric Oxide Releasing Aspirin (NCX 4016)|
|Study Start Date :||July 2006|
- Effects of nitric oxide-releasing acetylsalicyclic acid (NCX 4016) on aberrant cryptic foci (ACF) multiplicity after the second dose at 6 months
- Pharmacokinetic profile by blood, urine, and colon tissue sampling
- Incidence of ACF as measured by magnification chromoendoscopy
- 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
- Data on C-Reactive protein as a marker for inflammation
- Safety and tolerability of long-term oral administration of NCX 4016 as measured by NCI CTCAE v3.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331786
|United States, New York|
|Stony Brook University Cancer Center|
|Stony Brook, New York, United States, 11794-8174|
|Principal Investigator:||Basil Rigas, MD||Stony Brook University|