Using Aspirin to Improve Immunological Features of Ovarian Tumors

Eligibility Criteria

• * Participants that are greater than or equal to 18 years of age
• * For U.S. sites, patients can read and understand English or Spanish; for Canadian site, participants can read and understand English or French
• * Histology confirmed, or clinical suspicion of, invasive epithelial ovarian, fallopian tube, or peritoneal carcinoma. Must be grade 2 or 3 or high (where high is defined as grade 2/3). All histologies including serous, endometrioid, clear cell sarcoma, or carcinosarcoma histology is acceptable. Mixed histology also acceptable.
• * Treatment naïve for this cancer diagnosis
• * Planned for neoadjuvant chemotherapy (platinum-based doublet with taxane +/- anti-VEGF antibody) for at least 3 but no more than 5 cycles followed by an interval debulking surgery. \[Note: this study evaluates response while on neoadjuvant treatment. The final collection of specimen and questionnaire is at the time of surgery and immediate post-operative state. Therefore, there are no eligibility criteria related to treatment in the adjuvant setting (e.g., intraperitoneal treatment) and adjuvant therapy should proceed as the physician deems appropriate.\]
• * Measurable disease as defined by RECIST 1.1, CT scan (with or without contrast) within 12 weeks of study enrollment.
• * Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2
• * Able to provide tissue biopsy (core or excisional) sufficient for diagnosis and biomarker analysis, may use outside archival tissue if available.
• * If currently using anti-coagulation medication, no contraindication for temporary stoppage of use during the study based on physician judgement
• * Willing and able to swallow pills without difficulty
• * Un-transfused platelet count \> 100,000 cells/μL
• * Willing and able to participate in all required evaluations and procedures in this study protocol (e.g. undergoing treatment, scheduled visits and examinations, serum testing, questionnaires, pill log/diary)
• * Absolute neutrophil count \> 1.5 x 109 cells/L
• * Hemoglobin \> 9.0 g/dL, may use transfusions and the value can be post-transfusion
• * Estimated creatinine clearance of \> 30 mL/min, calculated using the formula Cockcroft-Gault \[(140-age) x Mass (kg)/(72 x creatinine mg/dL)\] x 0.85 for female
• * No severe hepatic impairment defined as AST or ALT elevation \< 2.5 x institutional ULN, unless liver metastasis is present \< 5 x ULN
• * Definite contraindication for either aspirin use or stopping current aspirin use based on physician's clinical judgment
• * History of vascular event in the last 12 months (e.g., myocardial infarction or unstable angina, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant \[serious or significant\] arrhythmias, significant vascular disease, congestive heart failure or vascular interventions).
• * History of hypertensive crisis and/ or uncontrolled HTN, systolic blood pressure \> 150 mmHg; diastolic blood pressure \> 90mmHg. Participants must have blood pressure \< 150/90 mmHg taken in a clinic setting by a medical professional within 2 weeks prior to starting study.
• * Current or history of ulcers which prohibits aspirin consumption, severe hepatic failure, or acute or chronic renal disease where aspirin use is contraindicated
• * History of gastrointestinal or genitourinary bleeding or other bleeding diathesis or coagulopathy within 6 months prior to enrollment of study
• * Uncontrolled erosive esophagitis requiring 2 or more treatments
• * Other cancer diagnosis in the last 3 years other than non-melanoma skin cancer
• * Autoimmune disorder requiring systemic therapy
• * Chronic steroid use defined as 3 weeks in the past year or any length of time in the past 30 days.
• * Other aspirin or NSAID hypersensitivities or contraindications (e.g. allergy)
• * History of bariatric surgery
• * Currently pregnant at the Screening visit or planning on becoming pregnant during the study period
• * Participant is unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with study medication.
• * Metabolism CYP2C9, known G6PD deficient patients