Using Aspirin to Improve Immunological Features of Ovarian Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Aspirin 325mg
- Placebo
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
United States Department of Defense
Collaborator
Sharp
Collaborator
Source ClinicalTrials.gov