Oral Minoxidil for Platinum-Resistant Ovarian Cancer

Overseen By Mary Beth Bartolotta, RN

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Loyola University

Must not be taking: Investigational agents

Disqualifiers: Brain metastases, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

34 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any other investigational agents or have had chemotherapy or radiotherapy within 4 weeks.

How does the drug Minoxidil differ from other treatments for platinum-resistant ovarian cancer?

Oral Minoxidil is unique for platinum-resistant ovarian cancer as it is traditionally used for treating high blood pressure and hair loss, not cancer. This makes its use in ovarian cancer novel, as it may work through different mechanisms compared to standard chemotherapy drugs like Taxol, which are typically used for this condition. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Margaret Liotta, DO

Principal Investigator

Loyola University

Eligibility Criteria

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.

Inclusion Criteria

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

My ovarian cancer has come back and does not respond to platinum-based treatments.

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

Exclusion Criteria

Participants must not be receiving any other investigational agents.

You cannot have had allergic reactions to minoxidil.

I do not have congestive heart failure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral minoxidil daily for the treatment of recurrent platinum resistant ovarian cancer

8 weeks

2 visits (in-person) at the end of each 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• Minoxidil

Trial Overview 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.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Loyola University

Lead Sponsor

Trials

161

Recruited

31,400+

Cures Within Reach

Collaborator

Trials

25

Recruited

2,100+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Findings from Research

Docetaxel has shown comparable effectiveness to paclitaxel when combined with carboplatin for treating advanced ovarian cancer, with a potentially better safety profile.

Current treatments for platinum-resistant ovarian cancer are limited, and while some experimental therapies targeting the epidermal growth factor receptor show promise, more research is needed to find effective new treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New aspects by the therapy of ovarian cancer--What changes after the ASCO-Meeting 2001]. Costa, SD., von Minckwitz, G., Wernicke, K., et al.[2008]

Despite high initial response rates to surgery and platinum-based chemotherapy in ovarian cancer, most patients experience relapse, highlighting the need for new treatment strategies to improve survival.

Recent phase III trials have shown that the anti-angiogenic agent bevacizumab, when used alongside chemotherapy and as maintenance therapy, can positively impact outcomes in first-line ovarian cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal first-line treatment in ovarian cancer. Raja, FA., Chopra, N., Ledermann, JA.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Taxol in epithelial ovarian cancer. [2015]

2. Germany pubmed.ncbi.nlm.nih.gov

[New aspects by the therapy of ovarian cancer--What changes after the ASCO-Meeting 2001]. [2008]

3. England pubmed.ncbi.nlm.nih.gov

Optimal first-line treatment in ovarian cancer. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Emerging drugs for ovarian cancer. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Management of platinum-sensitive recurrent ovarian cancer. [2022]