Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer (NCT04457089) | Clinical Trial Compass
CompletedEarly Phase 1
Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer
United States18 participantsStarted 2021-01-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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%
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)