Study on Zafirlukast for Treating Ovarian Cancer That Has Returned Based on Tumor Markers

Sponsor: Beth Israel Deaconess Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04339140

Provider View

This clinical trial is testing whether the drug Zafirlukast can help control ovarian cancer that has returned, as indicated by tumor markers, without visible tumors. The study aims to see if Zafirlukast can reduce tumor markers and the risk of blood clots.

Patient Parameters

Program Overview

The purpose of this study is to find out if Zafirlukast can help prevent tumor activity in women with ovarian cancer that has returned, as shown by tumor markers. Zafirlukast is a drug currently approved for treating asthma, but it has shown potential in lab studies to fight ovarian cancer. This study will involve about 30 participants who will receive the treatment for up to one year and be monitored for another year. The FDA has not approved Zafirlukast for ovarian cancer, but the National Institutes of Health is supporting this research.

Description

This study is a phase 2 clinical trial to see if Zafirlukast can lower the tumor marker CA-125 and reduce blood clot formation in women whose ovarian cancer has returned, as indicated by tumor markers. Participants will be screened for eligibility and will receive the study treatment, which includes evaluations and follow-up visits. The study will last up to one year, with an additional year of follow-up. About 30 women will participate. Zafirlukast is not FDA-approved for ovarian cancer but is approved for asthma. Recent lab studies suggest it may help fight ovarian cancer, though these results have not been confirmed in humans. The study is funded by the National Institutes of Health.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • Must have completed initial chemotherapy and surgery with a positive response, meaning no disease progression or rising CA-125 during treatment.
  • Must have tumor marker-only relapse, with CA-125 levels more than twice the normal limit or twice the lowest count on two tests without visible tumors.
  • Must be 18 years or older.
  • Must have a life expectancy of more than 4 months.
  • Must have a performance status score of 2 or less, indicating ability to perform daily activities.
  • Must be able to swallow tablets.
  • Must have adequate organ and bone marrow function based on specific blood tests.
  • Women of childbearing potential must use effective birth control during the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot have non-epithelial tumors or low malignant potential ovarian tumors.
  • Cannot have had chemotherapy or radiotherapy within 4 weeks before the study, except for stable maintenance therapy with certain drugs.
  • Cannot have ongoing severe side effects from previous cancer treatments.
  • Cannot be taking other experimental drugs.
  • Cannot have known brain metastases.
  • Cannot have allergies to similar drugs as Zafirlukast.
  • Cannot be on blood thinners or certain medications that interact with Zafirlukast.
  • Cannot have uncontrolled illnesses or psychiatric conditions that affect study participation.
  • Pregnant or breastfeeding women cannot participate due to potential risks to the baby.

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