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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 84 days
Awards & highlights
Study Summary
This trial is testing whether or not Zafirlukast can help to prevent ovarian cancer tumor activity in people who have already been diagnosed with the disease.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 84 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~84 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CA-125 Response Rate
Secondary outcome measures
Plasma D-Dimer Response Rate
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
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,010,200 Total Patients Enrolled
13 Trials studying Ovarian Cancer
496 Patients Enrolled for Ovarian Cancer
Dana-Farber Cancer InstituteOTHER
1,079 Previous Clinical Trials
340,918 Total Patients Enrolled
39 Trials studying Ovarian Cancer
4,500 Patients Enrolled for Ovarian Cancer
National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
7,492,289 Total Patients Enrolled
13 Trials studying Ovarian Cancer
943 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have side effects from cancer treatment, but they are mild except for hair loss or nerve issues.I am 18 years old or older.My CA-125 levels have doubled without signs of cancer on scans.I am not pregnant or breastfeeding.I am currently on blood thinner medication.I haven't had chemotherapy or radiotherapy in the last 4 weeks, but may be on a stable dose of certain maintenance medications.I am currently taking certain blood thinners or anti-inflammatory medications daily.My ovarian tumor is not primarily cancerous or is a specific rare type.I've completed initial chemotherapy and surgery for my cancer without it getting worse.I can swallow pills.I am 18 years old or older.I am not taking any drugs that affect CYP2C9 enzyme activity.I am a woman who can become pregnant and agree to use birth control during the study.I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.I do not have brain metastases.You have had allergic reactions to drugs similar to zafirlukast.I do not have any unmanaged ongoing illnesses.You are expected to live for at least 4 more months.My blood counts and kidney and liver functions are within normal ranges.I can take care of myself but might not be able to do heavy physical work.
Research Study Groups:
This trial has the following groups:- Group 1: Zafirlukast
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the trial participant pool currently comprised?
"Affirmative, clinicaltrials.gov has evidence indicating that this medical experimentation is currently recruiting participants. This trial was initially posted on June 24th 2020 and the listing was most recently revised on November 11th 2022; 30 patients are expected to be recruited from a single site."
Answered by AI
Has the Food and Drug Administration (FDA) given clearance to Zafirlukast?
"With Phase 2 trial data suggesting some safety, our team at Power has scored Zafirlukast's security a 2. Unfortunately, no efficacy findings have been reported yet."
Answered by AI
Could you outline any other experiments conducted with Zafirlukast?
"Currently, only 1 clinical trial is active for Zafirlukast. None of these have reached Phase 3 yet. Most studies are based in Boston, MA but one other location is also running trials for this medication."
Answered by AI
Does this research endeavor have room for additional participants?
"Affirmative, clinicaltrials.gov data affirms that this research study is actively searching for participants; it was first posted on June 24th 2020 and last updated November 11th 2022. 30 patients need to be recruited across a single medical site."
Answered by AI
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