Recruiting

Early Phase 1

AspirinUsing Aspirin to Improve Immunological Features of Ovarian Tumors

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT05080946

Conditions

Ovarian Cancer

Fallopian Tube Cancer

Peritoneal Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aspirin 325mg

Placebo

Study Details

Brief 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

Conditions

Ovarian Cancer

Fallopian Tube Cancer

Peritoneal Cancer

Study ID

NCT05080946

Start date

Nov 2, 2021

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants Randomized to Aspirin

Participants randomized to this arm will receive 325mg daily dose aspirin

placebo comparator: Participants Randomized to Placebo

Participants randomized to this arm will receive a daily dose of a placebo (inactive substance)

Interventions

Aspirin 325mg

Participants will receive a tablet of 325mg aspirin that is taken once daily by mouth. Study treatment begins on first day of neoadjuvant chemotherapy for up to 5 "cycles". Participants will be expected to take the study treatment for between 63 and 175 days (3-5 cycles). Participants will stop taking study treatment 7 days prior to participants interval debulking surgery.

Placebo

Participants will receive a placebo tablet that is taken once daily by mouth. Study treatment begins on first day of neoadjuvant chemotherapy for up to 5 "cycles". Participants will be expected to take the study treatment for between 63 and 175 days (3-5 cycles). Participants will stop taking study treatment 7 days prior to participants interval debulking surgery.

Primary outcome measure

Change in intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells from diagnostic biopsy to interval debulking surgery [ Time Frame: Up to 5 months ]
Change in intratumoral density of M2 tumor-associated macrophages (CD163+ cells) from diagnostic biopsy to interval debulking surgery [ Time Frame: Up to 5 Months ]

Central Contacts and Locations

Central contacts

Tiffany Shiles

813-745-2948 Tiffany.Shiles@moffitt.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Tiffany Shiles

813-745-2948 Tiffany.Shiles@moffitt.org

Jing-Yi Chern, MD

813-745-7205 Jing-Yi.Chern@moffitt.org

Principal Investigator:

Jing-YI Chern, MD

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Yukie Bean

503-418-4522 BeanY@ohsu.edu

Alberta Barnes

barnealb@ohsu.edu

Principal Investigator:

Elizabeth Munro, MD

University of Virginia Comprehensive Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22903

Principal Investigator:

Matt Wagar, MD

Inova Schar Cancer Institute

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Eibhleann Cojocari

571-472-0246 Eibhleann.Cojocari@inova.org

Principal Investigator:

Christina Annunziata, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-07-10.