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

• Status: Completed
• Trial end date: 2019-09-26
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: Wilma Williams Education and Clinical Research for Endometrial Cancer Award
• Treatments: Atorvastatin; Atorvastatin Calcium; Ezetimibe

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