What side effects are associated with this type of intervention?

Common treatments for ovarian cancer include chemotherapy agents such as paclitaxel, pegylated liposomal doxorubicin (PLD), and topotecan. Paclitaxel can cause neuropathy, alopecia, and myelosuppression. PLD is associated with less myelosuppression and alopecia but can cause hand-foot syndrome and mucositis. Topotecan's side effects include myelosuppression and gastrointestinal symptoms. While Minoxidil, a potassium channel opener/vasodilator, is being studied for its efficacy in recurrent platinum-resistant ovarian cancer, its known side effects in other contexts include hypertrichosis and cardiovascular effects such as tachycardia and fluid retention.

What other types of research exist?

Promising alternatives to Minoxidil for ovarian cancer treatment include: 1) Olaparib, a PARP inhibitor, which has shown improvement in progression-free survival in patients with platinum-sensitive relapsed ovarian cancer. 2) Rucaparib, another PARP inhibitor, effective as both maintenance therapy and monotherapy for recurrent, platinum-sensitive ovarian cancer. 3) Cediranib, an oral anti-angiogenic agent, which has demonstrated efficacy in recurrent or persistent endometrial cancer and may be considered for ovarian cancer. These alternatives have shown potential in clinical studies and could be considered for treatment in 2024.

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Vasodilator

Oral Minoxidil for Platinum-Resistant Ovarian Cancer

Q: What prior FDA approvals exist?

The FDA has approved several treatments for ovarian cancer, including chemotherapy agents like paclitaxel and carboplatin, targeted therapies such as PARP inhibitors (e.g., olaparib, niraparib, and rucaparib), and angiogenesis inhibitors like bevacizumab. While Minoxidil, a potassium channel opener and vasodilator, is being studied for its efficacy in recurrent platinum-resistant ovarian cancer, there are no current FDA-approved treatments in this specific category for ovarian cancer. The focus remains on chemotherapy, targeted therapies, and angiogenesis inhibitors.

Phase 2

Recruiting

Led By Margaret Liotta, DO

Research Sponsored by Loyola University

Eligibility Criteria Checklist

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

Must have

Participants must have platinum resistant disease defined as recurrence less than 6 months after initial platinum based treatment.

Participants must have an Eastern Cooperative Group (ECOG) Performance Status (PS) less than or equal to 2.

Must not have

Participants must not have congestive heart failure

Participants must not have brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Summary

This trial is testing if minoxidil, a blood pressure medication, can help treat ovarian cancer that doesn't respond to standard treatments. It works by changing the cell's internal environment to stop cancer growth. The study aims to see if it can reduce tumor size with fewer side effects.

Who is the study for?

This trial is for adults over 18 with recurrent platinum-resistant ovarian cancer, who can take pills and have an ECOG Performance Status of 2 or less. They must not have had chemo or radiotherapy in the last 4 weeks, be on other trials, have heart failure or disease, be on dialysis, have brain metastases, allergies to minoxidil, or uncontrolled high blood pressure.

What is being tested?

The study tests if oral Minoxidil helps patients with recurrent platinum-resistant ovarian cancer. It looks at how many respond to treatment, time before the disease gets worse again and records any side effects. It also explores whether a genetic factor (Kir6/SUR complex) affects Minoxidil's effectiveness.

What are the potential side effects?

Minoxidil may cause side effects such as fluid retention leading to rapid weight gain; swelling of face, hands, ankles; difficulty breathing; fast heartbeat; nausea; vomiting; breast pain/tenderness; changes in hair growth/loss.

Eligibility Criteria

Inclusion Criteria

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

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My cancer came back within 6 months after platinum-based treatment.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

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I can take medicine by mouth.

Exclusion Criteria

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

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I do not have congestive heart failure.

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I do not have cancer that has spread to my brain.

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My blood pressure is under control.

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I have no history of heart disease.

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I am not on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall response rate (ORR)

Secondary study objectives

Progression-free survival (PFS)

Side effects data

From 2015 Phase 2 trial • 21 Patients • NCT00876200

56%

Hypertrichosis

11%

Strabismus correction

100%

80%

60%

40%

20%

Study treatment Arm

Minoxidil

Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Participants in this arm will be treated with minoxidil. This treatment will be given daily by mouth.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Minoxidil

2011

Completed Phase 2

~170

0 / 9Eligibility 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 chemotherapy agents such as paclitaxel, which stabilizes microtubules and inhibits cell division, and topotecan, which inhibits topoisomerase I, leading to DNA damage and cell death. Pegylated liposomal doxorubicin intercalates DNA and inhibits topoisomerase II, causing apoptosis. Targeted therapies like bevacizumab inhibit vascular endothelial growth factor (VEGF), reducing tumor blood supply. Minoxidil, a potassium channel opener and vasodilator, is being studied for its potential to disrupt cancer cell proliferation by altering cellular ion balance and improving drug delivery through enhanced blood flow. Understanding these mechanisms is crucial for tailoring treatments to improve efficacy and manage resistance in ovarian cancer patients.