Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension

June 3, 2014 updated by: University of Chicago

A Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension With Direct Vasodilators, Minoxidil and Hydralazine

The purpose of this study is to describe the length of time and extent of blood pressure response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular endothelial growth factor (VEGF) inhibitor treatment induced hypertension.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ongoing treatment for malignancy by at the University of Chicago with any agent with recognized, specific inhibition of VEGF, VEGF-receptors, or downstream signaling molecules with the specific intention of inhibiting signaling of this pathway. These agents include but are not limited to: bevacizumab (Avastin™), sorafenib (Nexavar™), sunitinib (Sutent™), axitinib (AG-013736), and AZD 2171.
  • Treatment of hypertension with at least 2 or more anti-hypertensive medications with blood pressure remaining greater than 140/90 mmHg.
  • Stable management of other toxicities from the cancer treatments
  • Expected to continue current cancer treatments for at least 4 weeks
  • 18 years and older
  • Ability to understand and the willingness to sign a written informed consent document prior to any study specific procedures.

Exclusion Criteria:

  • Concurrent use of hematopoietic supportive treatment with erythropoietin or congeners.
  • Current uncontrolled toxicities due to the cancer treatments.
  • Patients having known contraindications to hydralazine or minoxidil therapy.
  • Any readings of systolic blood pressure >200 mmHg or diastolic blood pressure >120 mmHg in the four (4) weeks prior to screening.
  • Use of either minoxidil or hydralazine in the six (6) months prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Minoxidil
Drug: Minoxidil
2.5 mg taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
Active Comparator: 2
Hydralazine
Drug: Hydralazine
25 mg taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Magnitude of Change in Blood Pressure
Time Frame: 21 days
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Michael Maitland, M.D., Ph.D., University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

January 22, 2008

First Submitted That Met QC Criteria

January 22, 2008

First Posted (Estimate)

February 5, 2008

Study Record Updates

Last Update Posted (Estimate)

June 10, 2014

Last Update Submitted That Met QC Criteria

June 3, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15386B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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