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

Last updated: January 8, 2025
Sponsor: Bobbie Jo Rimel, MD
Overall Status: Active - Not Recruiting

Phase

1

Condition

Allergy (Pediatric)

Allergy

Ovarian Cysts

Treatment

Simvastatin 40mg

Clinical Study ID

NCT04457089
IIT2020-03-Rimel-STOV
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Recurrent platinum sensitive ovarian cancer, all histologies (serous, endometrioid,mucinous, clear cell). Platinum sensitivity defined as ≥ 6 months since lastplatinum treatment.

  • No contraindication to carboplatin and/or liposomal doxorubicin or simvastatin.

Exclusion

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 5drinks per day)

  • Prior exposure to doxorubicin or liposomal doxorubicin

  • Hemoglobin A1C >8.0%

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: Simvastatin 40mg
Phase: 1
Study Start date:
January 25, 2021
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

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