Can a common cholesterol pill help chemotherapy fight ovarian cancer?
NCT ID NCT07815704
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
Researchers are studying whether adding daily atorvastatin to standard chemotherapy and surgery changes the immune cells inside advanced high grade serous tumors of the ovary, fallopian tube, or peritoneum. The trial enrolls 40 adults with Stage III or IV disease who cannot have upfront surgery. Participants receive atorvastatin alongside carboplatin and paclitaxel chemotherapy before and after interval debulking surgery. The main question is whether the drug reduces tumor-promoting macrophages, a type of immune cell that can help tumors grow.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- atorvastatin, a common cholesterol-lowering statin pill
- What this could lead to
- If it works, adding a cheap, widely used statin could become a simple way to shift the tumor's immune environment and help standard treatment work better for advanced ovarian cancer.
- What could go wrong
- This is a small Phase 2 trial of 40 people, so any immune-cell changes may not translate into longer survival. Atorvastatin can cause muscle aches and rare liver or muscle problems, and it may not alter the tumor enough to matter.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 89 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Be a patient with ovarian cancer aged 18-89 * Diagnosed via tissue biopsy not ascites * For persons of reproductive potential, use of highly effective method(s) of contraception. * Patients with primary Stage III/IV high-grade serous ovarian/fallopian tube/primary peritoneal cancer not amenable to upfront cytoreductive surgery. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2. * Absolute Neutrophil Count 1500 cells/mL * Platelet count \> 100,000 mL. * Hemoglobin 9.0 g/dL * Serum albumin ³ 2.5 g/dL. * Total bilirubin ≤ 1.5 x upper limit of normal (ULN). * aspartate aminotransferase (AST )and alanine aminotransferase (ALT) ≤ 3.0 x ULN. * Serum creatinine ≤ 1.5x ULN Exclusion Criteria: * Inability to comply with study and follow-up procedures. * Significant cardiovascular disease, such as New York Heart Association cardiac disease (class II or greater), myocardial infarction within the past 3 months, unstable arrhythmia, or unstable angina. * Known clinically significant liver disease defined as AST and ALT \> 3.0 x ULN and/or total bilirubin ≥ 1.5 x ULN, or documented history of active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease. * Participation in investigational clinical trial within last 30 days. * Medical history of untreated HIV infection. Patients with medical history of HIV infection are eligible provided they meet following criteria * Are stable on antiretroviral therapy for ≥4 weeks before randomization * Agree to adhere to antiretroviral therapy per World Health Organization (WHO) guidelines * Have no documented multi-drug resistance that would prevent effective antiretroviral therapy * Have a viral load of \<400 copies per mL at screening * Have CD4+ T cell count at ≥ 350 cells per μL * Have no history of acquired immunodeficiency syndrome (AIDS) -defining opportunistic infection ≤ 12 months before randomization. * Inability to provide informed consent. * Known central nervous system (CNS) malignancy or CNS metastases. * Patients with previous malignancy within the past 2 years from cycle 1, day 1, except those with negligible risk of metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the breast. * History of stroke or transient ischemic attack (TIA) within 3 months prior to cycle 1 day 1(C1D1). * Patients with prognosis for survival less than 6 months. * Patients deemed otherwise clinically unfit for clinical trial per Investigator's discretion. * Patients with duodenal stent or other gastrointestinal (GI) disorder/defect that would interfere with absorption of oral medication. o Includes patients unable to swallow orally administered medication and patients with GI disorders likely to interfere with absorption of the study medication * Female patients who maintain fertility potential and refuse to comply to use contraception and be followed for pregnancy by pregnancy testing. * Patients who are currently pregnant or lactating. * Prior or current statin use that would prohibit randomization into SOC arm. * Planned treatment with bevacizumab in the primary treatment setting. * Diagnosis based on ascites assessment only and not a tissue biopsy. * Patients deemed otherwise clinically unfit for clinical trial per investigators discretion
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Colorado Anschutz
Aurora, Colorado, 80045, United States
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