Status:
COMPLETED
Aspirin in Preventing Colorectal Cancer in Patients at Increased Risk of Colorectal Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Colon Cancer
Precancerous Condition
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE2
Brief Summary
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 kee...
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 increas...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00468910
Start Date
March 1 2007
End Date
August 1 2011
Last Update
May 31 2017
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611