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

NCT ID: NCT05272462

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-13
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Minoxidil

Intervention Type: DRUG

Minoxidil is an antihypertensive vasodilator medication commonly used for the treatment of high blood pressure and pattern hair loss.

Interventions

Minoxidil

Minoxidil is an antihypertensive vasodilator medication commonly used for the treatment of high blood pressure and pattern hair loss.

Intervention Type: DRUG

Other Intervention Names

Rogaine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cures Within Reach

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Margaret Liotta

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaret Liotta, DO

Role: PRINCIPAL_INVESTIGATOR

Loyola University

Locations

Loyola University Medical Center

Maywood, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Margaret Liotta, DO

Role: CONTACT

mliotta@lumc.edu

708-216-5423

Mary Beth Bartolotta, RN

Role: CONTACT

mbartolotta@luc.edu

708-327-3222

Facility Contacts

Margaret Liotta, DO

Role: primary

mliotta@lumc.edu

708-216-5423

Mary Beth Bartolotta, RN

Role: backup

mbartolotta@luc.edu

708-327-3222

Other Identifiers

214787

Identifier Type: -

Identifier Source: org_study_id