Spots Global Cancer Trial Database for A Pre-Op Window Study Evaluating Anti-Proliferative Effects of Atorvastatin on the Endometrium

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Trial Identification

Brief Title: A Pre-Op Window Study Evaluating Anti-Proliferative Effects of Atorvastatin on the Endometrium

Official Title: Evaluating the Anti-Proliferative Effects of Atorvastatin on the Endometrium of Endometrial Cancer Patients: A Pre-Operative Window Study

Study ID: NCT02767362

Conditions

Endometrial Cancer

Interventions

Atorvastatin

Study Description

Brief Summary: This is a preoperative window, phase 0 study of short-term atorvastatin treatment in obese women who are to undergo surgical staging for endometrial cancer.

Detailed Description: This is a preoperative window, phase 0 study of short-term atorvastatin treatment in obese women who are to undergo surgical staging for endometrial cancer. After recruitment is completed, 24 paired endometrial biopsies and hysterectomy specimens from endometrial cancer patients treated at University of North Carolina at Chapel Hill will be retrospectively obtained from the Department of Pathology to serve as controls. These cases will be matched for stage and grade to the endometrial cancers of those women enrolled on this phase 0 clinical trial and will undergo the same immunohistochemical analysis. Two previous phase 0 window studies of metformin in endometrial cancer have found no difference in Ki-67 expression between preoperative endometrial biopsy and hysterectomy specimen in control patients, although a difference was seen in metformin treated patients. However, the investigators plan to include a control group to ensure that changes found between pre- and post-atorvastatin treated patients are due to the effects of this drug versus differences in the type of specimen examined (i.e. endometrial biopsy specimen obtained in clinic versus hysterectomy specimen obtained at the time of surgery). In addition, enrolled patients will undergo repeat endometrial biopsy post- atorvastatin treatment at the time of their surgical staging. Thus, study investigators plan to compare pre-treatment endometrial biopsies to both post-treatment endometrial biopsies and hysterectomy specimens as well as have a historical control group.