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Atorvastatin with or without Aspirin in Preventing Colorectal Cancer in Patients with Lynch Syndrome

Trial Status: Active

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.

Inclusion Criteria

  • Able to read and sign an informed consent document in English
  • Eligible subjects will have molecular evidence of Lynch Syndrome (mutation in MLH1, MSH2, MSH6, EPCAM or PMS2)
  • Subjects will be stratified (23 patients/arm) to receive: 1) atorvastatin (20 mg) daily—subjects have no colorectal adenomas within 5 years and no history of colorectal cancer ever; or 2) aspirin (325 mg)/atorvastatin (20 mg) daily—subjects may have a history of adenomas within 5 years and/or a history of colorectal cancer if surgically cured and > 1 year from completion of adjuvant chemotherapy

Exclusion Criteria

  • Unable to read and sign an informed consent document in English
  • Have active cancer or are less than 3 years post hormonal maintenance therapy for cancer
  • Have statin intolerance or contraindication for aspirin or atorvastatin use
  • Are pregnant or are actively breast feeding

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Contact: Michael John Hall
Phone: 800-325-4145

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.

Trial Phase Phase O

Trial Type Prevention

Lead Organization
Fox Chase Cancer Center

Principal Investigator
Michael John Hall

  • Primary ID 18-1039
  • Secondary IDs NCI-2018-02548
  • Clinicaltrials.gov ID NCT04379999