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

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

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.

Study Phase

Early Phase 1

Study Type

Interventional

Primary Outcome

Absolute difference score

Condition

Endometrial Cancer

Intervention

Atorvastatin

Study Arms / Comparison Groups

 Single Arm

Description:  Patients will undergo atorvastatin treatment for a minimum of 2 weeks but no more than a maximum of 4 weeks prior to surgery. At the time of hysterectomy and surgical staging, women will undergo repeat endometrial biopsy in the operating room under general anesthesia.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

November 2015

Completion Date

September 26, 2019

Primary Completion Date

September 26, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Be between the ages of 18-75 years old

          -  Have a confirmed diagnosis of type I endometrial cancer (endometrioid) based on
             pre-operative endometrial biopsy or dilation and curettage (D&C)

          -  Have a BMI >30

          -  Have no contraindication to short-term atorvastatin therapy

          -  Have a serum creatinine ≤ 1.0 mg/dL

          -  Have normal serum transaminase values (AST and ALT)

          -  Need to be able to undergo atorvastatin treatment for a minimum of 2 weeks but no more
             than a maximum of 4 weeks prior to surgical staging

        Exclusion Criteria:

          -  Are currently taking a statin or have taken a statin in the past 6 months or have a
             history of an allergic reaction or intolerance at any time to a statin

          -  Have a history of liver or renal dysfunction

          -  Have a history of alcoholism

          -  Are pregnant

          -  Are currently taking any hormonal therapy or have been on hormonal therapy in the past
             4 weeks

          -  Are taking a drug that may significantly interact or influence the metabolism of
             atorvastatin

          -  Concomitant cyclosporine, gemfibrozil, telaprevir, or tipranavir/ritonavir use

          -  History of stroke or transient ischemic attack in the preceding 6 months

Gender

Female

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Leslie Clark, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02767362

Organization ID

LCCC 1514

Responsible Party

Sponsor

Study Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

 Wilma Williams Education and Clinical Research for Endometrial Cancer Award

Study Sponsor

Leslie Clark, MD, Principal Investigator, UNC Lineberger Comprehensive Cancer Center

Verification Date

July 2020