Using Aspirin to Improve Immunological Features of Ovarian Tumors

  • STATUS
    Recruiting
  • End date
    Mar 23, 2025
  • participants needed
    100
  • sponsor
    H. Lee Moffitt Cancer Center and Research Institute
Updated on 23 December 2021
ct scan
aspirin
platelet count
measurable disease
carcinoma
metastasis
neutrophil count
cancer chemotherapy
fallopian tube
taxane
carcinosarcoma
peritoneal carcinoma
tumor debulking
interval debulking surgery

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

Details
Condition Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Treatment Placebo, Aspirin 325mg
Clinical Study IdentifierNCT05080946
SponsorH. Lee Moffitt Cancer Center and Research Institute
Last Modified on23 December 2021

Eligibility

Yes No Not Sure

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. All histologies including serous, endometrioid, clear cell sarcoma, or carcinosarcoma histology is acceptable. Mixed histology also acceptable
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.]
Treatment naïve for this cancer diagnosis
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
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)
Un-transfused platelet count > 100,000 cells/μL
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
Other cancer diagnosis in the last 3 years other than non-melanoma skin cancer
Uncontrolled erosive esophagitis requiring 2 or more treatments
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
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