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

NCT00331786 | Completed Phase 1

• 2 other identifiers: CDR0000473094SUNY-UH-20055574
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

colon cancer; rectal cancer

Outcome Measures

Primary Outcomes (1)

• Effects of nitric oxide-releasing acetylsalicyclic acid (NCX 4016) on aberrant cryptic foci (ACF) multiplicity after the second dose at 6 months

Secondary Outcomes (5)

• 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

Interventions

nitric oxide-releasing acetylsalicylic acid derivative DRUG

laboratory biomarker analysis OTHER

biopsy PROCEDURE

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * At risk for colorectal cancer * History of histologically proven sporadic colon adenomas or colon cancer * At least 5 aberrant cryptic foci on sigmoidoscopy * Less than 20 prior cumulative adenomas and no heredity nonpolyposis colorectal cancer * No significant asymptomatic lesions on sigmoidoscopy, including any of the following: * Inflammation * Strictures * Anorectal lesions * Fistulae * Vascular lesions * No adenomas or colon carcinomas on flexible sigmoidoscopy * No history of gastrointestinal (GI) cancer other than colorectal cancer * No inherited colorectal cancer syndromes 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) * No active peptic ulcer disease * No history of inflammatory bowel disease (ulcerative colitis or Crohn's disease) * No known or suspected alcohol ( \> 5 glasses of wine or beer per day), drug, or medication abuse * No quantitative or qualitative platelet or coagulation abnormalities * No personal or family history of a bleeding disorder * No uncontrolled diabetes * No uncontrolled hypertension, or chronic congestive heart failure (New York Heart Association class II-IV heart disease) * No myocardial infarction, transient ischemic attack, or stroke within the past 6 months * No equilibrium disorders affecting gait or ability to stand that would preclude study participation * No involuntary change in weight (up or down) of ≥ 15% of usual body weight within the past year * Creatinine ≤ 2.0 mg/dL * No chronic liver disease or pancreatitis * No allergies to aspirin * No prior severe adverse reactions to NSAIDs such as asthma, GI bleeding, or renal insufficiency * No institutionalized, mentally disabled patients * No prisoners * Not pregnant or nursing * Fertile patients must use effective contraception * Negative pregnancy test PRIOR CONCURRENT THERAPY: * No concurrent antibiotic prophylaxis * More than 7 days since prior nonsteroidal anti-inflammatory drug (NSAID) treatment, including aspirin * No concurrent frequent use (\> 7 days in previous month) of NSAIDs, cyclooxygenase (COX)-2 inhibitors, nitrovasodilators, or oral corticosteroids * No concurrent macronutrient consumption below the 1st or above the 99th percentile of U.S. consumption * No concurrent anticoagulants, ticlopidine, and clopidogrel * More than 3 months since prior general anesthesia * More than 3 months since prior investigational agents * No concurrent NSAIDs, including aspirin or COX-2 inhibitors * Acetaminophen allowed * No concurrent nitrovasodilating drugs * More than 3 months since prior participation in other investigational trials

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Stony Brook University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stony Brook University Cancer Center

Stony Brook, New York, 11794-8174, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

nitroaspirin; Biopsy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Basil Rigas, MD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 30, 2006
• First Posted: May 31, 2006
• Study Start: July 1, 2006
• Last Updated: February 9, 2009

Record last verified: 2007-05

Locations

US (1)