The purpose of the study is to evaluate the effectiveness of aspirin with neoadjuvant chemotherapy for decreasing markers of immune suppression in the tumor at interval debulking surgery, in women with diagnosed ovarian, fallopian tube, or peritoneal carcinoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Participants will receive a tablet of 325mg aspirin that is taken once daily by mouth. Study treatment begins on first day of neoadjuvant chemotherapy for up to 5 "cycles". Participants will be expected to take the study treatment for between 63 and 175 days (3-5 cycles). Participants will stop taking study treatment 7 days prior to participants interval debulking surgery.
Participants will receive a placebo tablet that is taken once daily by mouth. Study treatment begins on first day of neoadjuvant chemotherapy for up to 5 "cycles". Participants will be expected to take the study treatment for between 63 and 175 days (3-5 cycles). Participants will stop taking study treatment 7 days prior to participants interval debulking surgery.
Moffitt Cancer Center
Tampa, Florida, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Change in intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells from diagnostic biopsy to interval debulking surgery
Change in intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells will be measured by using this formula: (density in the debulking surgery tissue sample - density in the biopsy tissue sample)\*100 / density in the biopsy tissue sample.
Time frame: Up to 5 months
Change in intratumoral density of M2 tumor-associated macrophages (CD163+ cells) from diagnostic biopsy to interval debulking surgery
Change in intratumoral density of of M2 tumor-associated macrophages (CD163+ cells) will be measured by using this formula: (density in the debulking surgery tissue sample - density in the biopsy tissue sample)\*100 / density in the biopsy tissue sample.
Time frame: Up to 5 Months
Change in density of tumor COX1
Change in density of tumor COX1 will be measured by using this formula: (density in the debulking surgery tissue sample - density in the biopsy tissue sample)\*100 / density in the biopsy tissue sample.
Time frame: Up to 5 Months
Change in density of tumor COX2
Change in density of tumor COX2 will be measured by using this formula: (density in the debulking surgery tissue sample - density in the biopsy tissue sample)\*100 / density in the biopsy tissue sample.
Time frame: Up to 5 Months
Change in blood levels of IL-6
Investigators will calculate the percent change in the concentration of the biomarker from baseline to Visit 4
Time frame: Up to 84 days
Change in blood levels of p-selectin
Investigators will calculate the percent change in the concentration of the biomarker from baseline to Visit 4
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Time frame: Up to 84 days
Change in blood levels of CA 125
Investigators will calculate the percent change in the concentration of the biomarker from baseline to Visit 4
Time frame: Up to 84 days
Change in tumor burden as defined by RECIST 1.1
Change in tumor burden be assessed using Response Evaluation Criteria in Solid Tumors guideline version 1.1 (RECIST 1.1)
Time frame: Up to 5 Months