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| Sponsor: | Stony Brook University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00331786 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: nitric oxide-releasing acetylsalicylic acid derivative Other: laboratory biomarker analysis Procedure: biopsy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Phase I Multiple-Dose Safety, Pharmacokinetic and Pharmacodynamic Clinical Study of Nitric Oxide Releasing Aspirin (NCX 4016) |
| Estimated Enrollment: | 240 |
| Study Start Date: | July 2006 |
OBJECTIVES:
Primary
Secondary
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.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At risk for colorectal cancer
No significant asymptomatic lesions on sigmoidoscopy, including any of the following:
PATIENT CHARACTERISTICS:
No other GI mucosal epithelial diseases (e.g., Barrett's esophagus, chronic or recurrent peptic ulcer disease, celiac sprue, or other disorders of nutrient absorption)
PRIOR CONCURRENT THERAPY:
No concurrent NSAIDs, including aspirin or COX-2 inhibitors
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00331786 History of Changes |
| Other Study ID Numbers: | CDR0000473094, SUNY-UH-20055574 |
| Study First Received: | May 30, 2006 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
colon cancer rectal cancer |
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Aspirin Nitroaspirin Nitric Oxide Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors |