Clinical trial NCT04457089: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Recurrent Ovarian Cancer
Platinum-sensitive Ovarian Cancer
Keywords: simvastatin
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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%

Primary outcomes:
measure: Completion of the simvastatin intervention with at least 85% compliance
timeFrame: From Cycle 1 Day 1 until Cycle 6 Day 28 (each cycle is 28 days)
Secondary outcomes:
measure: Response by CA125
timeFrame: From baseline until 12 months
measure: Progression-free survival
timeFrame: From baseline until 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Bobbie Jo Rimel, MD
role: PRINCIPAL_INVESTIGATOR
References: