Pilot Study to Assess the Efficacy of Aspirin to Improve Immunological Features of Ovarian Tumors
The purpose of the study is to evaluate the effectiveness of aspirin with neoadjuvant chemotherapy for decreasing markers or immune suppression in the tumor at interval debulking surgery, in women with diagnosed ovarian, fallopian tube, or peritoneal carcinoma
Primary Objective: To evaluate the efficacy of aspirin with neoadjuvant chemotherapy for decreasing markers of immune suppression (tumor-associated macrophages and T-regulatory cells) in the tumor at interval debulking surgery.
Secondary Objectives: To evaluate the efficacy of aspirin for reducing tumor burden and tumor COX1/COX2 expression. Will also examine the efficacy of aspirin for reducing plasma inflammatory markers (IL-6 and p-selectin) and CA 125. Throughout the course of the investigation, additional relevant biomarkers may be evaluated.
Tertiary Objectives: To monitor the safety and toxicity of aspirin use in this population. We will also compare patient-reported emotional distress (depression, anxiety), gastrointestinal (nausea and vomiting, gastroesophageal reflux, belly pain, gas and bloating, diarrhea), and other physical and cognitive symptoms (sleep quality and sleep-related impairment, fatigue, cognitive function, neuropathic pain, general pain, bruising) in ovarian cancer patients randomly assigned to aspirin versus placebo.
Patients that are greater than or equal to 18 years of age
Histology confirmed, or clinical suspicion of, invasive epithelial ovarian, fallopian tube, or peritoneal carcinoma. Must be grade 2 or 3. Serous, endometrioid, 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
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. Patients must have blood pressure > 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
Active diagnosis of reflux esophagitis
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
Patient unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with study medication.
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