This pilot phase 0 trial studies the effect of atorvastatin calcium on cellular growth in obese patients with type I endometrial cancer. Atorvastatin calcium is commonly used in the treatment of high cholesterol and results in lower blood levels of cholesterol. It works by blocking a protein needed for cholesterol to form. Studying samples from patients with endometrial cancer before and after they are treated with atorvastatin calcium may help doctors learn more about its activity against cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02767362.
PRIMARY OBJECTIVE:
I. To evaluate marker of proliferation Ki-67 (Ki-67) proliferation with pre- and post- (atorvastatin [atorvastatin calcium]) treatment Ki-67 measurements in obese women with type I endometrial carcinoma (EC).
SECONDARY OBJECTIVE:
I. To evaluate 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMG-CoA reductase) and key targets of the mitogen-activated protein kinase (MAPK)/ mechanistic target of rapamycin (mTOR) pathways pre- and post-atorvastatin treatment.
EXPLORATORY OBJECTIVES:
I. To explore possible associations of the above noted biomarker measures, including their change measures, and with patients’ response to treatment.
II. To identify and explore potential biomarkers shared by endometrial cancer tumors and their associated biofluids (i.e. serum and urine) and their possible association to this treatment regimen through metabolomic profiling.
III. To evaluate circulating tumor cells (CTCs) pre- and post- treatment and explore a possible association with patient response.
OUTLINE:
Patients receive atorvastatin calcium orally (PO) daily for 2-4 weeks. Patients also undergo tissue, urine, and blood sample collection at baseline and after completion of treatment.
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorLeslie H. Clark
