Clinical trial NCT02767362: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Endometrial Cancer
Keywords: atorvastatin
endometrium
endometrial cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Wilma Williams Education and Clinical Research for Endometrial Cancer Award
First posted: 2016-05-10
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Absolute difference score
timeFrame: Two Years
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Leslie Clark, MD
role: PRINCIPAL_INVESTIGATOR
References: