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Oral Minoxidil for the Treatment of Recurrent Platinum Resistant Epithelial Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05272462
Recruitment Status : Recruiting
First Posted : March 9, 2022
Last Update Posted : June 29, 2022
Sponsor:
Collaborators:
Cures Within Reach
Medical University of South Carolina
Information provided by (Responsible Party):
Margaret Liotta, Loyola University

Study Description
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Brief Summary:
The primary purpose of this study is to determine the response rate of patients with recurrent platinum resistant ovarian cancer when treated with oral minoxidil. Secondary objectives include estimating the time to disease progression while on minoxidil and to describe the toxicities of minoxidil when used for patients with recurrent platinum resistant ovarian cancer. An exploratory objective is to evaluate if efficacy of minoxidil is improved in patients that have the Kir6/SUR complex versus those that do not.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Minoxidil Phase 2

Detailed Description:

Minoxidil is approved by the Food and Drug Administration (FDA) for treatment of hypertension. In previous studies, the sulfonylurea receptor (SUR) subunit controls the selectivity of the pharmacological response to drugs that either inhibit or stimulate the Kir6/SUR channel. Oral minoxidil acts as an activator of the Kir6/SUR2 channel upon selective binding to sulfonylurea receptor 2 (SUR2). Activation of the Kir6.2 potassium channel by minoxidil leads to potassium outflow and calcium entry which produces a cytoplasmic electrical charge that is more negative. This in turn creates an attractive force for calcium to enter the cell. Increased intracellular calcium disrupts mechanisms of cell division by arresting the cell cycle in G2/M phase and this is associated with alteration of the oxidative state, disruption of the mitochondria and activation of the caspase-3-independent cell death pathway.

Evaluation of arrest of tumor growth was evaluated in a previous study. This was done in vitro as well as in vivo by establishing a xenograft model from a Kir6.2/SUR2 positive high grade serous ovarian cancer cell line. In the mice treated with minoxidil, five of the 6 mice had no evidence of measurable disease at necropsy. In contrast, the untreated mice were found to have carcinomatosis and ascites in all 6 mice, demonstrating tumor reduction with minoxidil treatment.

While recurrent ovarian cancer can be treated with a multitude of drugs, the response rates are limited. Treatment options can also be limited secondary to myelosuppression as a result of patients being heavily pretreated. Minoxidil appears to have the advantage of not causing severe myelosuppression which can limit treatment options for patients. Laboratory results provide promising evidence that minoxidil could be used for the treatment of recurrent ovarian cancer.

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 cancer. The primary goal is to assess whether treatment with minoxidil will reduce tumor burden in patients with recurrent ovarian cancer and have a minimal toxicity profile.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a non-randomized prospective single-site trial of minoxidil for patients living with recurrent platinum resistant ovarian cancer.
Masking: None (Open Label)
Masking Description: This study is an open-label Phase II trial
Primary Purpose: Treatment
Official Title: A Phase II Trial of Oral Minoxidil for the Treatment of Recurrent Platinum Resistant Epithelial Ovarian Cancer
Actual Study Start Date : December 13, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Minoxidil

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Participants in this arm will be treated with minoxidil. This treatment will be given daily by mouth.
 Drug: Minoxidil
Minoxidil is an antihypertensive vasodilator medication commonly used for the treatment of high blood pressure and pattern hair loss.
Other Name: Rogaine


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: At the end of Cycle 2 (each cycle is 28 days) ]
    The ORR is defined as the percentage of participants who experience a complete response (CR), partial response (PR), or stable disease (SD) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0)


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Up to 24 months ]
    PFS is defined as the time from receipt of minoxidil to the first documented progression of disease or death due to any cause, whichever occurred first


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Participants must have recurrent platinum resistant ovarian cancer. Histologic documentation of the recurrence is not required.
  • Participants must have platinum resistant disease defined as recurrence less than 6 months after initial platinum based treatment.
  • Participants must be greater than or equal to 18 years of age.
  • Participants must have an Eastern Cooperative Group (ECOG) Performance Status (PS) less than or equal to 2.
  • Participants must be able to take oral medications.

Exclusion Criteria

  • Participants must not have had chemotherapy or radiotherapy within 4 weeks
  • Participants must not be receiving any other investigational agents.
  • Participants must not have brain metastases
  • Participants must not have allergic reactions to minoxidil
  • Participants must not have congestive heart failure
  • Participants must not have history of cardiac disease
  • Participants must not have uncontrolled hypertension
  • Participants must not be on dialysis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05272462


Contacts
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Contact: Margaret Liotta, DO 708-216-5423 mliotta@lumc.edu
Contact: Mary Beth Bartolotta, RN 708-327-3222 mbartolotta@luc.edu

Locations
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United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Margaret Liotta, DO    708-216-5423    mliotta@lumc.edu   
Contact: Mary Beth Bartolotta, RN    708-327-3222    mbartolotta@luc.edu   
Principal Investigator: Margaret Liotta, DO         
Sponsors and Collaborators
Loyola University
Cures Within Reach
Medical University of South Carolina
Investigators
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Principal Investigator: Margaret Liotta, DO Loyola University
More Information
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Responsible Party: Margaret Liotta, Associate Professor, Loyola University
ClinicalTrials.gov Identifier: NCT05272462    
Other Study ID Numbers: 214787
First Posted: March 9, 2022    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Margaret Liotta, Loyola University:
Ovarian Cancer
Platinum Resistant
Epithelial Ovarian Cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Minoxidil
Antihypertensive Agents
Vasodilator Agents