This early phase I trial studies how well atorvastatin with or without aspirin work in preventing colorectal cancer in patients with Lynch syndrome. Atorvastatin may lower the risk of developing cancers in the colon and rectum. Aspirin may reduce the risk of colon polyps and colon cancers. Giving atorvastatin and aspirin may work better at treating colorectal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04379999.
PRIMARY OBJECTIVE:
I. Conduct an exploratory biomarker trial in healthy patients (previously unaffected and cancer survivors) with Lynch syndrome.
SECONDARY OBJECTIVES:
I. To explore the rate of adherence of healthy patients with Lynch Syndrome to the 6-week treatment regimen (atorvastatin +/- aspirin).
II. To explore the frequency of adverse events among patients administered atorvastatin +/- aspirin for 6 weeks.
III. To explore the microbiome profile of patients pre- versus (vs.) on-treatment (6 weeks of atorvastatin +/- aspirin).
IV. To explore the association between treatment–induced changes in biomarker levels and the presence of single nucleotide polymorphisms in key drug metabolism genes.
V. To explore the acceptability of the pilot study intervention and the willingness of the subject to participate in a similar larger study.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients receive atorvastatin orally (PO) once daily (QD) for 6 weeks after colonoscopy.
GROUP II: Patients receive atorvastatin and aspirin PO QD for 6 weeks after colonoscopy.
Lead OrganizationFox Chase Cancer Center
Principal InvestigatorMichael John Hall
