Using Aspirin to Improve Immunological Features of Ovarian Tumors

Inclusion 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 Canadiansite, 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 isdefined as grade 2/3). All histologies including serous, endometrioid, clear cellsarcoma, 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 intervaldebulking surgery. [Note: this study evaluates response while on neoadjuvanttreatment. The final collection of specimen and questionnaire is at the time ofsurgery and immediate post-operative state. Therefore, there are no eligibilitycriteria related to treatment in the adjuvant setting (e.g., intraperitonealtreatment) 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 andbiomarker analysis, may use outside archival tissue if available.

• If currently using anti-coagulation medication, no contraindication for temporarystoppage 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 thisstudy protocol (e.g. undergoing treatment, scheduled visits and examinations, serumtesting, 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 formulaCockcroft-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 institutionalULN, unless liver metastasis is present < 5 x ULN

Exclusion Criteria:

• Definite contraindication for either aspirin use or stopping current aspirin usebased on physician's clinical judgment

• History of vascular event in the last 12 months (e.g., myocardial infarction orunstable angina, stroke, coronary artery angioplasty or stenting, coronary arterybypass graft, relevant [serious or significant] arrhythmias, significant vasculardisease, 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 priorto starting study.

• Current or history of ulcers which prohibits aspirin consumption, severe hepaticfailure, or acute or chronic renal disease where aspirin use is contraindicated

• History of gastrointestinal or genitourinary bleeding or other bleeding diathesis orcoagulopathy 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 thepast 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 duringthe study period

• Participant is unable to swallow orally administered medication and patients withgastrointestinal disorders likely to interfere with study medication.

• Metabolism CYP2C9, known G6PD deficient patients