Actively Recruiting

Early Phase 1
Age: 18Years +
FEMALE
NCT05080946

Using Aspirin to Improve Immunological Features of Ovarian Tumors

Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-01

100

Participants Needed

4

Research Sites

265 weeks

Total Duration

On this page

Sponsors

H

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Using Aspirin to Improve Immunological Features of Ovarian Tumors

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 18 years or older
  • Able to read and understand English or Spanish (U.S. sites) or English or French (Canadian site)
  • Histologically confirmed or clinically suspected invasive epithelial ovarian, fallopian tube, or peritoneal carcinoma of grade 2 or 3 or high
  • Treatment naive for this cancer diagnosis
  • Planned for neoadjuvant chemotherapy with platinum-based doublet and taxane, with or without anti-VEGF antibody, for 3 to 5 cycles followed by interval debulking surgery
  • Measurable disease by RECIST 1.1 with CT scan within 12 weeks before enrollment
  • ECOG performance status 0, 1, or 2
  • Able to provide tissue biopsy sufficient for diagnosis and biomarker analysis
  • If using anti-coagulation medication, no contraindication to temporary stoppage during study
  • Willing and able to swallow pills without difficulty
  • Platelet count above 100,000 cells/bcL without transfusion
  • Willing and able to participate in all study procedures including treatment, visits, tests, and questionnaires
  • Absolute neutrophil count above 1.5 x 10^9 cells/L
  • Hemoglobin above 9.0 g/dL (post-transfusion allowed)
  • Estimated creatinine clearance above 30 mL/min using Cockcroft-Gault formula
  • No severe liver impairment (AST or ALT less than 2.5 times institutional upper limit, unless liver metastasis present under 5 times limit)
Not Eligible

You will not qualify if you...

  • Definite contraindication to aspirin use or stopping current aspirin use
  • History of vascular events in the last 12 months (e.g., heart attack, stroke, unstable angina, coronary interventions, arrhythmias, heart failure)
  • History of hypertensive crisis or uncontrolled blood pressure over 150/90 mmHg
  • Current or history of ulcers prohibiting aspirin use, severe liver failure, or kidney disease contraindicating aspirin
  • History of gastrointestinal or genitourinary bleeding or bleeding disorders within 6 months
  • Uncontrolled erosive esophagitis requiring multiple treatments
  • Other cancers diagnosed within the last 3 years except non-melanoma skin cancer
  • Autoimmune disorders needing systemic therapy
  • Chronic steroid use within past year or past 30 days
  • Allergies or contraindications to aspirin or NSAIDs
  • History of bariatric surgery
  • Pregnant or planning to become pregnant during the study
  • Unable to swallow oral medication or with gastrointestinal disorders interfering with medication
  • Known CYP2C9 metabolism issues or G6PD deficiency

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Actively Recruiting

2

Oregon Health and Science University

Portland, Oregon, United States, 97239

Actively Recruiting

3

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, United States, 22903

Actively Recruiting

4

Inova Schar Cancer Institute

Fairfax, Virginia, United States, 22031

Actively Recruiting

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Research Team

T

Tiffany Shiles

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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Using Aspirin to Improve Immunological Features of Ovarian Tumors | DecenTrialz