Aspirin in Preventing Colorectal Cancer in Patients at Increased Risk of Colorectal Cancer
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Purpose
This randomized phase II trial is studying how well aspirin works in preventing colorectal cancer in patients at increased risk of colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of aspirin may prevent colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colon Cancer Precancerous Condition Rectal Cancer |
Drug: acetylsalicylic acid Drug: placebo Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Spectral Markers in Aspirin Chemoprevention of Colonic Neoplasia |
- Change in spectral slope [ Time Frame: From baseline to 3 months after completion of study treatment ] [ Designated as safety issue: No ]The difference in the observed change from baseline in each arm, aspirin and placebo, will be compared.
- Change in fractal dimension [ Time Frame: From baseline to 3 months after completion of study treatment ] [ Designated as safety issue: No ]The difference in the observed change from baseline in each arm, aspirin and placebo, will be compared.
- Colonic epithelial apoptosis as measured by immunohistochemical detection of cleaved caspase 3 [ Time Frame: Up to 3 months after completion of study treatment ] [ Designated as safety issue: No ]
- Colonic cell proliferation as measured by immunohistochemical detection of Ki67 [ Time Frame: Up to 3 months after completion of study treatment ] [ Designated as safety issue: No ]
- Rectal prostaglandin levels as measured by ELISA [ Time Frame: Up to 3 months after completion of study treatment ] [ Designated as safety issue: No ]
- Platelet cyclooxygenase (COX) activity as measured by a peroxidase-based COX enzyme activity assay [ Time Frame: Up to 3 months after completion of study treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 115 |
| Study Start Date: | March 2007 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral acetylsalicylic acid (aspirin) once daily.
|
Drug: acetylsalicylic acid
Given orally
Other Names:
Other: laboratory biomarker analysis
Correlative study
|
|
Placebo Comparator: Arm II
Patients receive oral placebo once daily.
|
Drug: placebo
Given orally
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative study
|
Detailed Description:
PRIMARY OBJECTIVE:
I. Determine whether acetylsalicylic acid (aspirin) will alter spectral markers (i.e., spectral slope and fractal dimension) in distal colonic mucosa of patients who are at increased risk for the development or recurrence of colorectal cancer.
SECONDARY OBJECTIVES:
I. Assess the effect of this drug on colonic epithelial apoptosis and cell proliferation in these patients.
II. Assess the effect of this drug on rectal prostaglandin levels in these patients.
III. Assess the effect of this drug on platelet cyclooxygenase activity in these patients.
IV. Correlate changes in spectral markers with UGT1A6 genotype in patients treated with this drug.
OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled study. Patients are stratified by clinical site and adenoma/carcinoma maximal size. Patients with abnormal spectral biomarkers are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral acetylsalicylic acid (aspirin) once daily.
ARM II: Patients receive oral placebo once daily.
In both arms, treatment continues for 3 months in the absence of unacceptable toxicity.
Patients undergo flexible sigmoidoscopy and biopsies as well as blood collection at baseline (during prestudy colonoscopy) and at completion of study treatment for comparison of spectral signatures with biomarkers of both aspirin activity (including plasma cyclooxygenase activity and rectal prostaglandin levels) as well as with biomarkers associated with antineoplastic alteration (including apoptosis and cell proliferation). UGT1A6 genotyping analysis is also performed.
After completion of study treatment, patients are followed at 3 months.
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria:
- No active or metastatic cancer within the past 6 months
- Scheduled to undergo colonoscopy for colonic neoplasia surveillance
- Hemoglobin >= 12.0 g/dL
- Platelet count >= 120,000/mm^3
- AST or ALT =< 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase =< 1.5 times ULN
- Bilirubin =< 1.5 times ULN
- BUN =< 40 mg/dL
- Glomerular filtration rate >= 45 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No coagulopathy
- No anemia
- No history of peptic ulcer disease or gastrointestinal hemorrhage
- No history of cerebrovascular accident
- No uncontrolled hypertension
- No history of intolerance or allergy to aspirin or to NSAIDs
- No liver disease as manifested by signs or symptoms of cirrhosis
- No endoscopic or radiographic evidence of portal hypertension
- No active colitis by endoscopy
- No history of inflammatory bowel disease
- No requirement for aspirin as medical therapy (i.e., post-myocardial infarction or transient ischemic attack)
- No untreated helicobacter pylori infection
History of significant colonic neoplasia, defined as 1 of the following:
- Adenoma within the past 6 years
- Colorectal cancer within the past 6 years
- Known adenoma on present exam
- Histologically confirmed polyps seen on imaging
- INR =< 1.5
- At least 6 months since prior cancer treatment
- No other concurrent acetylsalicylic acid (aspirin)-containing products or non-steroidal anti-inflammatory drugs (NSAIDs)
- No concurrent systemic corticosteroids
- No other concurrent anticoagulants or antiplatelet agents
- No concurrent investigational drugs
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00468910 History of Changes |
| Other Study ID Numbers: | NCI-2009-00841, NCI 04-2-03, CDR0000652929, N01CN35157 |
| Study First Received: | May 2, 2007 |
| Last Updated: | May 21, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Additional relevant MeSH terms:
|
Colonic Neoplasms Rectal Neoplasms Colorectal Neoplasms Precancerous Conditions Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Aspirin |
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 |
ClinicalTrials.gov processed this record on May 22, 2013