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
24
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