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

NCT ID: NCT04457089

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2026-01-31

Brief Summary

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.

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.

Conditions

Recurrent Ovarian Cancer; Platinum-sensitive Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simvastatin

Group Type: EXPERIMENTAL

Simvastatin 40mg

Intervention Type: DRUG

Simvastatin 40mg by mouth nightly for approximately 6 months during treatment with carboplatin and liposomal doxorubicin

Interventions

Simvastatin 40mg

Simvastatin 40mg by mouth nightly for approximately 6 months during treatment with carboplatin and liposomal doxorubicin

Intervention Type: DRUG

Other Intervention Names

Zocor

Eligibility Criteria

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%

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Marc Goodman

OTHER

Sponsor Role: lead

Responsible Party

Marc Goodman

Oncologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bobbie Jo Rimel, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

IIT2020-03-Rimel-STOV

Identifier Type: -

Identifier Source: org_study_id