Clinical Trials /

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

NCT04457089

Description:

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.

Related Conditions:
  • Ovarian Clear Cell Adenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mucinous Adenocarcinoma
  • Ovarian Serous Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer
  • Official Title: Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer

Clinical Trial IDs

  • ORG STUDY ID: IIT2020-03-Rimel-STOV
  • NCT ID: NCT04457089

Conditions

  • Recurrent Ovarian Cancer
  • Platinum-sensitive Ovarian Cancer

Interventions

DrugSynonymsArms
Simvastatin 40mgZocorSimvastatin

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
SimvastatinExperimental
  • Simvastatin 40mg

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%
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure: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)
Safety Issue:
Description:Percentage of patients who complete the simvastatin intervention with at least 85% compliance during Carboplatin and Doxil chemotherapy.

Secondary Outcome Measures

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

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bobbie Jo Rimel, MD

Trial Keywords

  • simvastatin

Last Updated

January 28, 2021