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

Marc Goodman

Status and phase: Completed; Early Phase 1

Conditions: Platinum-sensitive Ovarian Cancer; Recurrent Ovarian Cancer

Treatments: Drug: Simvastatin 40mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04457089

IIT2020-03-Rimel-STOV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Simvastatin

Experimental group

Treatment:

Drug: Simvastatin 40mg