Back to search results

Aspirin for Ovarian, Fallopian Tube, or Peritoneal Cancer

This study is looking at whether aspirin can help improve the immune response within ovarian, fallopian tube, or peritoneal tumors. You would receive either a 325mg aspirin tablet or a placebo (an inactive pill) once daily by mouth. This treatment would start on the first day of your neoadjuvant chemotherapy (chemotherapy given before surgery) and continue for 3 to 5 cycles, which is about 63 to 175 days. Researchers will measure changes in specific immune cells within your tumor to see if aspirin helps reduce immune suppression. This study is for women aged 18 and older who have been diagnosed with ovarian, fallopian tube, or peritoneal cancer and can read English, Spanish, or French.

Study design
This interventional study plans to enroll 100 participants. It compares aspirin to a placebo, meaning some participants will receive aspirin and others will receive an inactive pill.
What's involved
You would take a pill (either aspirin or placebo) once daily by mouth for 3 to 5 cycles of chemotherapy, lasting between 63 and 175 days. Tumor biopsies will be taken at diagnosis and again at interval debulking surgery.
Compensation
Not stated in the trial record.
Follow-up
The main measurements for this study will be taken up to 5 months after starting treatment, specifically at the time of interval debulking surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05080946

Using Aspirin to Improve Immunological Features of Ovarian Tumors

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~100 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Aspirin 325mgPlacebo

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells from diagnostic biopsy to interval debulking surgery
Measured over Up to 5 months
+1 more outcome measured

Conditions

Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmMalignant Peritoneal Neoplasm

Where it's being run

4 sites across 3 states
Virginia2
Florida1
Oregon1

Study leadership

  • Jing-Yi Chern, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Tiffany Shiles
[email protected]
813-745-2948
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells from diagnostic biopsy to interval debulking surgeryUp to 5 months

    Change in intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells will be measured by using this formula: (density in the debulking surgery tissue sample - density in the biopsy tissue sample)\*100 / density in the biopsy tissue sample.

  • Change in intratumoral density of M2 tumor-associated macrophages (CD163+ cells) from diagnostic biopsy to interval debulking surgeryUp to 5 Months

    Change in intratumoral density of of M2 tumor-associated macrophages (CD163+ cells) will be measured by using this formula: (density in the debulking surgery tissue sample - density in the biopsy tissue sample)\*100 / density in the biopsy tissue sample.