Oral Minoxidil for Platinum-Resistant Ovarian Cancer

ML
MB
Overseen ByMary Beth Bartolotta, RN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of oral minoxidil for individuals with platinum-resistant ovarian cancer that has recurred after treatment. Researchers seek to determine the time it takes for the cancer to progress during this treatment and to identify any side effects. The study seeks participants whose ovarian cancer recurred less than six months after completing initial treatment with platinum-based drugs and who can take oral medications. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that oral minoxidil is likely to be safe for humans?

Research shows that oral minoxidil, originally used for high blood pressure, is under study for its potential to treat ovarian cancer unresponsive to standard treatments. Since minoxidil is already approved for other uses, researchers have some confidence in its safety. People using minoxidil for other conditions generally tolerate it well. However, like any medication, it can cause side effects. Common side effects include changes in blood pressure and heart rate, so monitoring these during treatment is important. While more detailed safety information specific to its use in ovarian cancer is still being collected, the ongoing study aims to identify any unique concerns. Participants should stay informed and regularly consult their healthcare providers throughout the trial.12345

Why do researchers think this study treatment might be promising for ovarian cancer?

Unlike the standard treatments for platinum-resistant ovarian cancer, which typically involve chemotherapy drugs like paclitaxel, oral minoxidil is being studied for its unique approach. Researchers are excited about minoxidil because it is traditionally known as a blood pressure medication and hair growth treatment, but it may offer a new mechanism of action for fighting cancer. This drug is taken orally, making it potentially more convenient and less invasive compared to intravenous chemotherapy. Additionally, minoxidil’s potential to attack cancer cells in a novel way could open up new avenues for treating this challenging condition.

What evidence suggests that oral minoxidil might be an effective treatment for platinum-resistant ovarian cancer?

Research has shown that oral minoxidil is under investigation as a potential treatment for ovarian cancer that resists standard therapies. Originally used to treat high blood pressure, scientists are exploring its effects on this type of cancer. Limited information exists on its efficacy for ovarian cancer, but it may influence processes that promote cancer growth. Early results suggest it could improve patient response to treatment, though further studies are necessary for confirmation. Participants in this trial will take minoxidil orally each day to assess its effectiveness and safety for this condition.13678

Who Is on the Research Team?

ML

Margaret Liotta, DO

Principal Investigator

Loyola University

Are You a Good Fit for This Trial?

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.
See 1 more

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.
See 5 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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

Citations

Oral Minoxidil for the Treatment of Recurrent Platinum ...This study plans to conduct a single center phase II study to evaluate the efficacy and safety of oral minoxidil in the treatment of platinum resistant ovarian ...
Oral Minoxidil for the Treatment of Recurrent Platinum ...The primary purpose of this study is to determine the response rate of patients with recurrent platinum resistant ovarian cancer when ...
3.thancfoundation-org.clinicaltrialconnect.comthancfoundation-org.clinicaltrialconnect.com/trials/NCT05272462
Oral Minoxidil for the Treatment of Recurrent Platinum ...The primary purpose of this study is to determine the response rate of patients with recurrent platinum resistant ovarian cancer when treated with oral ...
Oral Minoxidil for Platinum-Resistant Ovarian CancerThis trial is testing if minoxidil, a blood pressure medication, can help treat ovarian cancer that doesn't respond to standard treatments.
minoxidil Clinical Research TrialsThis study plans to conduct a single center phase II study to evaluate the efficacy and safety of oral minoxidil in the treatment of platinum resistant ovarian ...
Oral Minoxidil for the Treatment of Recurrent Platinum ...The primary purpose of this study is to determine the response rate of patients with recurrent platinum resistant ovarian cancer when treated with oral ...
Overcoming the challenges of drug development in platinum ...This review outlines existing data from contemporary clinical trials of patients with platinum-resistant ovarian cancer and suggests historical synthetic ...
Oral Minoxidil for the Treatment of Recurrent PlatinumThe primary purpose of this study is to determine the response rate of patients with recurrent platinum resistant ovarian cancer when treated with oral ...
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