RecruitingEarly Phase 1NCT05080946

Using Aspirin to Improve Immunological Features of Ovarian Tumors

Pilot Study to Assess the Efficacy of Aspirin to Improve Immunological Features of Ovarian Tumors

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

100 participants

Start Date

Nov 2, 2021

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether taking low-dose aspirin before surgery can improve the immune environment inside ovarian tumors, potentially helping the immune system fight the cancer better. **You may be eligible if...** - You are 18 or older with confirmed or suspected invasive epithelial ovarian, fallopian tube, or peritoneal carcinoma (grade 2 or 3) - You have not yet received any treatment for this cancer - You are planned to receive neoadjuvant chemotherapy (chemo before surgery) followed by interval debulking surgery - You can read and understand English, Spanish (for U.S. sites), or French (for Canadian site) - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You have already started treatment for this cancer - You cannot tolerate aspirin (allergy or bleeding risk) - You are pregnant or breastfeeding - Your general health is too poor (ECOG > 2) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAspirin 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.

DRUGPlacebo

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.