Isoquercetin for people with ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 randomized, placebo-controlled trial gives isoquercetin or a matching placebo to adults with histologically confirmed epithelial, serous, or clear cell ovarian cancer who are starting first-line chemotherapy. Treatment is started on day 1 of cycle 1 or 2 of chemotherapy and participants have serial blood tests to measure biomarkers linked to clotting risk. The main comparison is the change in those blood markers between the isoquercetin and placebo groups over the treatment period. The trial is led by Memorial Sloan Kettering Cancer Center with additional data collection at Beth Israel Deaconess.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Prior history of documented venous thromboembolic event within the last 2 years (excluding central line associated events whereby patients completed anticoagulation)
* Active bleeding or high risk for bleeding (e.g., known acute gastrointestinal ulcer)
* History of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 24 months
* Familial bleeding diathesis
* Known diagnosis of disseminated intravascular coagulation (DIC)
* Currently receiving anticoagulant therapy
* Current daily use of aspirin, clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox) (within 10 days) or considered to use regular use of higher doses of non-steroidal anti-inflammatory agents as determined by the treating physician (e.g ibuprofen \> 800 mg daily or equivalent)
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Known intolerance of (iso)quercetin, niacin or ascorbic acid (including known G6PD deficiency).
* Participants with known brain metastases
* Pregnant women are excluded from this study because isoquercetin is a PDI inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with isoquercetin, breastfeeding should be discontinued if the mother is treated with isoquercetin.

Where it's running

• Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (All Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (All Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (All Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activites)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Jeffrey Zwicker, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Jeffrey Zwicker, MD
• Email: zwickerj@mskcc.org
• Phone: 646-608-3723

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.