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

Early Phase 1

Active, not recruiting

• Conditions: Platinum-sensitive Ovarian Cancer; Recurrent Ovarian Cancer
• Interventions: Drug: Simvastatin 40mg

• Registration Number: NCT04457089
• Lead Sponsor: Bobbie Jo Rimel, MD

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.

Study Timeline

• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-07
• Study Start: 2021-01-25
• Primary Completion: 2024-11-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 18

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.

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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%

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Simvastatin	Simvastatin 40mg	-

Primary Outcome Measures

Name	Time	Method
Completion of the simvastatin intervention with at least 85% compliance	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.

Secondary Outcome Measures

Name	Time	Method
Response by CA125	From baseline until 12 months	Change in serum level of CA125
Progression-free survival	From baseline until 12 months	Duration until disease progression or death

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States