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.
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
| Drug | Synonyms | Arms |
|---|
| Simvastatin 40mg | Zocor | Simvastatin |
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
| Name | Type | Description | Interventions |
|---|
| Simvastatin | Experimental | | |
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
Last Updated
August 18, 2021
