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New treatment option for Ovarian Cancer
Official title Using Aspirin to Improve Immunological Features of Ovarian Tumors
ClinicalTrials.gov ID: NCT05080946
What this study is testing
What is Aspirin 325mg?
Aspirin 325mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- History of hypertensive crisis and/ or uncontrolled HTN, systolic blood pressure \> 150 mmHg; diastolic blood pressure \> 90mmHg. Participants must...
- Current or history of ulcers which prohibits aspirin consumption, severe hepatic failure, or acute or chronic renal disease where aspirin use is...
- 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
See the full eligibility 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...
- 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...
- 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
- 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]...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Portland, Oregon, United States
- Charlottesville, Virginia, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Portland, Oregon, United States; Charlottesville, Virginia, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.