Randomized, Multi-dose, Placebo-controlled Phase 2 Trial of Oral Isoquercetin to Reduce Thrombin Generation in Ovarian Cancer
The purpose of this study is to test whether isoquercetin can reduce markers in the blood that may indicate the risk of blood clots in people with ovarian cancer. The effects of isoquercetin will be compared with those of a placebo.
• Participants must have histological- or cytological-confirmed ovarian cancer (epithelial, serous, or clear cell) and be receiving first-line chemotherapy (day 1 of isoquercetin should align with day 1 of cycle 1 or 2 of chemotherapy) for neoadjuvant, adjuvant, or advanced settings.
• Minimum age 18 years
• Life expectancy of greater than 6 months.
• ECOG performance status \<2
• Participants must have preserved organ and marrow function as defined below:
‣ Platelet count \> 50,000/mcL
⁃ Prothrombin time (PT) and partial thromboplastin time (PTT) \< 1.5 x institutional upper limit of normal (ULN)
⁃ Total bilirubin \< 3 x ULN without liver metastases and \<5 x ULN in presence of liver metastases.
⁃ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 X ULN without liver metastases and \<5 x ULN in the presence of liver metastases.
⁃ Estimated creatinine clearance (CrCl \>30 ml/min)
• The effects of isoquercetin on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document.