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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Neoadjuvant chemotherapy with carboplatin and paclitaxel in addition to daily atorvastatin, interval debulking surgery, then 2-3 additional cycles of carboplatin and paclitaxel
neoadjuvant chemotherapy with 3-4 cycles of carboplatin/paclitaxel, interval debulking surgery, then 2-3 additional cycles of chemotherapy with carboplatin/paclitaxel
University of Colorado Anschutz
Aurora, Colorado, United States
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.
Time frame: 3 months
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.
Time frame: 5 years
Overall Survival
Overall survival as defined by the time of randomization to time of death from any cause.
Time frame: 5 years
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