Aspirin to enhance immune response in ovarian cancer treatment

Pilot Study to Assess the Efficacy of Aspirin to Improve Immunological Features of Ovarian Tumors

This study is testing if taking aspirin along with chemotherapy can help boost the immune response in women with ovarian cancer to improve their treatment outcomes.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 4 sites (Tampa, Florida and 3 other locations)
• Trial ID: NCT05080946 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of aspirin in combination with neoadjuvant chemotherapy to reduce immune suppression markers in women diagnosed with ovarian, fallopian tube, or peritoneal carcinoma. Participants will receive either aspirin or a placebo during their chemotherapy treatment, with assessments made at the time of interval debulking surgery. The goal is to determine if aspirin can improve immunological features of the tumors, potentially leading to better surgical outcomes.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with confirmed invasive epithelial ovarian, fallopian tube, or peritoneal carcinoma who are treatment naïve and planned for neoadjuvant chemotherapy.

Not a fit: Patients with low-grade tumors or those who have previously received treatment for their cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the immune response against ovarian cancer, potentially improving treatment outcomes.

How similar studies have performed: While the use of aspirin in cancer treatment is being explored, this specific approach combining aspirin with neoadjuvant chemotherapy in ovarian cancer is relatively novel.

Eligibility criteria

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

Where this trial is running

Tampa, Florida and 3 other locations

• Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
• Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
• University of Virginia Comprehensive Cancer Center — Charlottesville, Virginia, United States (Recruiting)
• Inova Schar Cancer Institute — Fairfax, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Jing-Yi Chern, MD — Moffitt Cancer Center
• Study coordinator: Tiffany Shiles

Conditions Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer