What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as chemotherapy agents paclitaxel and carboplatin, often cause side effects including fatigue, nausea, vomiting, neuropathy, and hematologic toxicities like anemia and thrombocytopenia. Targeted therapies like olaparib, a PARP inhibitor, also frequently result in fatigue, gastrointestinal issues (nausea, vomiting), and decreased appetite. While specific data on Zafirlukast in ovarian cancer is limited, leukotriene receptor antagonists generally have a favorable side effect profile, with potential mild side effects such as headache, nausea, and respiratory infections.

What prior FDA approvals exist?

The FDA has approved several treatments for ovarian cancer, including rucaparib, a PARP inhibitor, for patients with deleterious BRCA mutation-associated advanced ovarian cancer who have been treated with two or more chemotherapies. Other PARP inhibitors like olaparib and niraparib have also been approved for similar indications. These drugs target specific genetic mutations and are part of a broader strategy to improve outcomes in ovarian cancer. While Zafirlukast, a leukotriene receptor antagonist, is being studied for its potential in treating marker-relapsed ovarian cancer, it represents a different therapeutic approach compared to the currently approved systemic therapies.

What other types of research exist?

Promising novel alternatives to Zafirlukast for ovarian cancer patients include: <ol> <li>Cediranib - A tyrosine kinase inhibitor showing promising results in clinical trials.</li> <li></li> </ol> Olaparib - A PARP inhibitor effective in platinum-sensitive ovarian cancer. 3. Farletuzumab - An antibody targeting folate receptor alpha, discussed for recurrent ovarian cancer. 4. Bevacizumab - An anti-angiogenic agent used in combination with chemotherapy for platinum-resistant ovarian cancer. 5. Nintedanib - Another tyrosine kinase inhibitor with potential benefits in ovarian cancer treatment.

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Leukotriene Inhibitor

Zafirlukast for Ovarian Cancer

Phase 2

Recruiting

Led By Jeffrey Zwicker, MD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Minimum age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of zafirlukast in participants under 18 years of age with ovarian cancer, children are excluded from this study but will be eligible for future pediatric trials.

Participants must meet criteria for tumor marker-only relapse, defined as CA-125 more than twice the upper limit of normal (35 U/mL) in the setting of a normal baseline CA-125 levels or CA-125 greater than twice the nadir count on two successive measurements for CA-125 values that remain above baseline without measurable radiographic disease.

Must not have

Pregnant women are excluded from this study because zafirlukast is a class B agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with zafirlukast, breastfeeding should be discontinued if the mother is treated with zafirlukast.

Currently receiving anticoagulant therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 84 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing Zafirlukast, an asthma medication, to see if it can help patients with relapsed ovarian cancer. The drug may reduce tumor activity and lower the risk of blood clots based on lab studies. Zafirlukast is commonly used to improve asthma control.

Who is the study for?

This trial is for adult women with a specific type of ovarian cancer that has relapsed, indicated only by tumor markers without visible disease. They must have finished initial chemotherapy and surgery successfully, be able to swallow pills, and use contraception if childbearing potential. Men and those with certain health conditions or on conflicting medications are excluded.

What is being tested?

The study tests Zafirlukast's effectiveness in preventing tumor activity in women whose ovarian cancer has returned but is only detectable through tumor markers rather than physical tumors. Participants will take Zafirlukast tablets to see if it can control the cancer's return.

What are the potential side effects?

Zafirlukast may cause allergic reactions in some people similar to other drugs they might be allergic to. It could also potentially affect fetal development; hence pregnant women cannot participate. Other side effects are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My CA-125 levels have doubled without signs of cancer on scans.

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I can swallow pills.

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I am 18 years old or older.

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I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.

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My blood counts and kidney and liver functions are within normal ranges.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I am currently on blood thinner medication.

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I am not taking any drugs that affect CYP2C9 enzyme activity.

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I do not have brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 84 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~84 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 84 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CA-125 Response Rate

Secondary study objectives

Plasma D-Dimer Response Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ZafirlukastExperimental Treatment1 Intervention

Zafirlukast will be taken orally at a pre-determined dose 2x daily for 28 day cycle up to 1 year.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zafirlukast

2007

Completed Phase 1

~50

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ovarian cancer include platinum-based chemotherapy, which works by causing DNA damage that leads to cancer cell death, and targeted therapies like PARP inhibitors, which prevent cancer cells from repairing DNA damage. Bevacizumab, an angiogenesis inhibitor, blocks the blood supply to tumors, inhibiting their growth. Zafirlukast, a leukotriene receptor antagonist, is being studied for its potential to prevent tumor activity by blocking leukotriene pathways involved in inflammation and cancer progression. Understanding these mechanisms is crucial for ovarian cancer patients as it helps in selecting the most effective treatment based on the tumor's specific characteristics and resistance patterns.

The Role of Eicosanoids in Gynecological Malignancies.Leukotriene B4 receptor-2 promotes invasiveness and metastasis of ovarian cancer cells through signal transducer and activator of transcription 3 (STAT3)-dependent up-regulation of matrix metalloproteinase 2.Current status of bevacizumab in advanced ovarian cancer.