Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer

February 2, 2026 updated by: Marc Goodman
This is a single arm pilot trial to evaluate the feasibility of using a simvastatin intervention, and to evaluate its effects on cancer progression, among 20 patients with platinum-sensitive ovarian cancer, treated with carboplatin and liposomal doxorubicin at Cedars-Sinai Medical Center.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a pilot study of statin therapy to examine the feasibility of simvastatin use to reduce disease progression in 20 patients with platinum-sensitive ovarian cancer at Cedars-Sinai Medical Center. This study will focus on patients with recurrent platinum sensitive ovarian cancer to increase the likelihood that this population will experience recurrent disease during the 6-month intervention and follow-up. In addition, this population of patients has a narrow range of standard of care carboplatin doublet combinations that are prescribed, enabling the investigators to create a more homogenous study population. Given their high risk of developing recurrent disease, women with platinum sensitive ovarian cancer, have the potential to derive the maximum benefit from an intervention that could delay disease progression and enhance survival.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Recurrent platinum sensitive ovarian cancer, all histologies (serous, endometrioid, mucinous, clear cell). Platinum sensitivity defined as ≥ 6 months since last platinum treatment.
  • No contraindication to carboplatin and/or liposomal doxorubicin or simvastatin.

Exclusion Criteria:

  • Prior or current use of any statin medication
  • Current systemic use of medications known to interact with statins
  • Current use of any other investigational agents
  • Liver disease, active cirrhosis
  • Uncontrolled intercurrent illness
  • History of chronic myopathy
  • Prior cancer other than ovarian cancer or non-melanomatous skin cancers
  • Known active infection with HIV
  • Current excessive alcohol consumption (average alcohol consumption of more than 5 drinks per day)
  • Prior exposure to doxorubicin or liposomal doxorubicin
  • Hemoglobin A1C >8.0%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simvastatin
Drug: Simvastatin 40mg
Simvastatin 40mg by mouth nightly for approximately 6 months during treatment with carboplatin and liposomal doxorubicin
Other Names:
  • Zocor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of the simvastatin intervention with at least 85% compliance
Time Frame: From Cycle 1 Day 1 until Cycle 6 Day 28 (each cycle is 28 days)
Percentage of patients who complete the simvastatin intervention with at least 85% compliance during Carboplatin and Doxil chemotherapy.
From Cycle 1 Day 1 until Cycle 6 Day 28 (each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response by CA125
Time Frame: From baseline until 12 months
Change in serum level of CA125
From baseline until 12 months
Progression-free survival
Time Frame: From baseline until 12 months
Duration until disease progression or death
From baseline until 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marc Goodman

Investigators

  • Principal Investigator: Bobbie Jo Rimel, MD, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2021

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

May 12, 2025

Study Registration Dates

First Submitted

June 25, 2020

First Submitted That Met QC Criteria

July 1, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2020-03-Rimel-STOV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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