H. Lee Moffitt Cancer Center and Research Institute
Dr. Liat Hogen
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 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
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 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