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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00607477
Recruitment Status : Terminated (Study has been terminated due to poor accrual.)
First Posted : February 5, 2008
Results First Posted : February 16, 2011
Last Update Posted : June 10, 2014
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Treatment Induced Hypertension Drug: Minoxidil Drug: Hydralazine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension With Direct Vasodilators, Minoxidil and Hydralazine
Study Start Date : January 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Magnitude of Change in Blood Pressure [ Time Frame: 21 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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): NCT00607477


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Michael Maitland, M.D., Ph.D. University of Chicago
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00607477    
Other Study ID Numbers: 15386B
First Posted: February 5, 2008    Key Record Dates
Results First Posted: February 16, 2011
Last Update Posted: June 10, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Minoxidil
 Hydralazine
Antihypertensive Agents
Vasodilator Agents