Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma

• Status: Active, not recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

Summary

This phase IIa trial studies how well aspirin works in preventing colorectal cancer in patients with colorectal adenoma. Aspirin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of colorectal adenoma of any grade

• Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

• Leukocytes >= 3,000/microliter

• Absolute neutrophil count >= 1,500/microliter

• Platelets >= 150,000/microliter

• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)

• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x institutional ULN

• Creatinine =<1.5 x institutional ULN

• Blood hemoglobin >= 12.0 g/dL

• Alkaline phosphatase =< 1.5 x institutional ULN

• Blood urea nitrogen (BUN) =< 40 mg/dL

• Estimated glomerular filtration rate (eGFR) >= 45 mL/min

• Negative fecal occult blood test

• The effects of aspirin on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Current (within three weeks of randomization) or planned use during the study intervention of the following:

• Aspirin, other nonsteroidal anti-inflammatory drugs (NSAIDs), or COX-2 inhibitors

• Anticoagulants, anti-platelet agents, or corticosteroids

• Gingko

• Ethanol consumption > 1 standard drinks/day for women, or > 2 standard drinks/day for men

• Methotrexate (MTX)

• Study participants will be instructed to use Tylenol or some other non-excluded agent to treat common ailments (i.e. headache/minor aches and pains)

• History of

• Any invasive malignancy within the past 2 years, with the exception of non-melanoma skin cancer

• Chronic renal diseases or liver cirrhosis

• Diseases such as anemia, peptic ulcer, gastrointestinal bleeding, active colitis and inflammatory bowel disease

• Hemorrhagic stroke or uncontrolled hypertension

• Participants may not be receiving any other investigational agents

• History of allergic reactions or intolerance attributed to aspirin or compounds of similar chemical or biologic composition

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements

• Women who are pregnant or breastfeeding; pregnant women are excluded from this study because aspirin has the potential for abortifacient effects; because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with aspirin, breastfeeding should be discontinued if the mother is treated with aspirin