The goal of this clinical trial is to learn how atorvastatin in patients with advanced high grade serous cancer of the ovary, fallopian tube, or peritoneum changes the tumor immune environment. The main question it aims to answer is:
* Does atorvastatin combined with standard of care chemotherapy and surgery changes the number of tumor-promoting macrophages in the tumor microenvironment * Researchers will compare standard of care chemotherapy and surgery to see if there is a difference in tumor promoting macrophages. * Participants will take atorvastatin (daily pill) alongside their standard treatment.
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.
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.
Parallel
Standard of Care + atorvastatin
DrugNeoadjuvant chemotherapy with carboplatin and paclitaxel in addition to daily atorvastatin, interval debulking surgery, then 2-3 additional cycles of carboplatin and paclitaxel
Standard of Care (SOC)
Drugneoadjuvant chemotherapy with 3-4 cycles of carboplatin/paclitaxel, interval debulking surgery, then 2-3 additional cycles of chemotherapy with carboplatin/paclitaxel
Change from baseline of CD163+ tumor associated macrophages in post-treatment specimens.
The primary efficacy endpoint is the change from baseline to the post-treatment surgical specimen in the mean CD163 H-score among CD68-positive tumor-associated macrophages. CD68 and CD163 expression will be assessed by multispectral immunohistochemistry in paired pre-treatment biopsy and post-treatment surgical samples.
Progression free survival
Investigator-assessed progression-free survival will be defined as the time from randomization to the first documented occurrence of objective disease progression or death from any cause, whichever occurs first.
Overall Survival
Overall survival as defined by the time of randomization to time of death from any cause.
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This trial is not recruiting at the moment. You can still explore other options:
