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Aspirin for Ovarian Cancer

Phase < 1
Recruiting
Led By Jing-Yi Chern, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants that are greater than or equal to 18 years of age
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 months
Awards & highlights

Study Summary

This trial is testing whether aspirin can decrease markers of immune suppression in ovarian cancer patients receiving chemotherapy.

Who is the study for?
This trial is for women aged 18+ with ovarian, fallopian tube, or peritoneal carcinoma who haven't started treatment. They must be able to read English/Spanish (U.S.) or English/French (Canada), have a certain disease severity and type, plan to undergo specific chemotherapy followed by surgery, and meet health criteria like blood counts and organ function.Check my eligibility
What is being tested?
The study tests if aspirin can boost the immune system's response to tumors when given with standard chemo before surgery in patients with certain types of female reproductive cancers. Participants will either receive aspirin or a placebo alongside their chemotherapy regimen.See study design
What are the potential side effects?
Aspirin may cause risks such as bleeding issues, digestive tract irritation like ulcers, allergic reactions in those sensitive to NSAIDs, and potential complications for those with clotting disorders or severe liver/renal conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My kidneys work well enough, based on a creatinine clearance test.
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I am set to receive specific chemotherapy before surgery for 3-5 cycles.
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My cancer is a type of ovarian, fallopian tube, or peritoneal and is grade 2 or higher.
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I have not received any treatment for my current cancer diagnosis.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in intratumoral density of M2 tumor-associated macrophages (CD163+ cells) from diagnostic biopsy to interval debulking surgery
Change in intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells from diagnostic biopsy to interval debulking surgery
Secondary outcome measures
Change in blood levels of CA 125
Change in blood levels of IL-6
Change in blood levels of p-selectin
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants Randomized to AspirinExperimental Treatment1 Intervention
Participants randomized to this arm will receive 325mg daily dose aspirin
Group II: Participants Randomized to PlaceboPlacebo Group1 Intervention
Participants randomized to this arm will receive a daily dose of a placebo (inactive substance)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin 325mg
2019
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

Sharp Clinical Services, IncUNKNOWN
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,392 Total Patients Enrolled
10 Trials studying Ovarian Cancer
517 Patients Enrolled for Ovarian Cancer
United States Department of DefenseFED
863 Previous Clinical Trials
227,532 Total Patients Enrolled
6 Trials studying Ovarian Cancer
1,755 Patients Enrolled for Ovarian Cancer

Media Library

Aspirin 325mg Clinical Trial Eligibility Overview. Trial Name: NCT05080946 — Phase < 1
Ovarian Cancer Research Study Groups: Participants Randomized to Aspirin, Participants Randomized to Placebo
Ovarian Cancer Clinical Trial 2023: Aspirin 325mg Highlights & Side Effects. Trial Name: NCT05080946 — Phase < 1
Aspirin 325mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT05080946 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Using Aspirin to Improve Immunological Features of Ovarian Tumors
2021. "Using Aspirin to Improve Immunological Features of Ovarian Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05080946.
All > Durlaza
~29 spots leftby May 2025
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