Overview

Using Aspirin to Improve Immunological Features of Ovarian Tumors

Status:
Recruiting
Trial end date:
2025-03-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of the study is to evaluate the effectiveness of aspirin with neoadjuvant chemotherapy for decreasing markers of immune suppression in the tumor at interval debulking surgery, in women with diagnosed ovarian, fallopian tube, or peritoneal carcinoma
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborators:
Sharp Clinical Services, Inc
United States Department of Defense
Treatments:
Aspirin
Criteria
Inclusion Criteria:

- Participants 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/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

- 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

- 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