Aspirin in Preventing Colorectal Cancer in Patients at Increased Risk of Colorectal Cancer

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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 keep cancer from forming. The use of aspirin may prevent colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Aspirin

Criteria

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