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

NCT02767362 | Completed Early Phase 1 DMC

• 1 other identifier: LCCC 1514
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Keywords

atorvastatin; endometrium; endometrial cancer

Outcome Measures

Primary Outcomes (1)

• Absolute difference score

  Measurement of the change in tumor proliferation as measured by Ki67 immunohistochemical staining after 2-4 weeks of treatment with atorvastatin. For visual comparisons of pre- and post-treatment measures, informative plots will be generated. For statistical comparisons of pre- and post-treatment measures absolute difference scores will be created. An absolute difference score is the subtraction of a post-treatment measurement from a pre-treatment measurement. The nonparametric Wilcoxon signed-rank tests will be used to examine the significance of the absolute difference scores for each measure of interest.

  Two Years

Study Arms (1)

Single Arm

EXPERIMENTAL

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.

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

Once enrolled on this pre-operative window study, patients with endometrial cancer will be treated with the standard clinical dose of atorvastatin (80 mg once daily orally) for an average of 2-4 weeks prior to surgical staging. Patients will 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.

Also known as: Ezetimibe

Single Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Wilma Williams Education and Clinical Research for Endometrial Cancer Award: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• UNC Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Atorvastatin; Ezetimibe

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Azetidines; Azetines

Study Officials

• Leslie Clark, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: May 10, 2016
• Study Start: November 1, 2015
• Primary Completion: September 26, 2019
• Study Completion: September 26, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

US (1)