Aspirin for the Improvement of Immunological Features of Ovarian Tumors in Patients Receiving Neoadjuvant Chemotherapy

Inclusion Criteria

• Patients 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, patients 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 naive 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 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, computed tomography (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/uL.
• 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 10^9 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.
• No severe hepatic impairment defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation =< 2.5 x institutional ULN, unless liver metastasis is present =< 5 x ULN.

Exclusion Criteria

• 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 hypertension (HTN), systolic blood pressure > 150 mmHg; diastolic blood pressure > 90mmHg. Patients 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 non-steroidal anti-inflammatory drug (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.
• Patient unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with study medication.
• Metabolism CYP2C9, known G6PD deficient patients.