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

This study has been terminated.
(Study has been terminated due to poor accrual.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00607477
First Posted: February 5, 2008
Last Update Posted: June 10, 2014
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.
Information provided by (Responsible Party):
University of Chicago
January 22, 2008
February 5, 2008
November 22, 2010
February 16, 2011
June 10, 2014
January 2008
January 2009   (Final data collection date for primary outcome measure)
Magnitude of Change in Blood Pressure [ Time Frame: 21 days ]
Time to and Magnitude of Change in Blood Pressure [ Time Frame: 21 days ]
Complete list of historical versions of study NCT00607477 on ClinicalTrials.gov Archive Site
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Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension
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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Treatment Induced Hypertension
  • 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
  • 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
  • Active Comparator: 1
    Minoxidil
    Intervention: Drug: Minoxidil
  • Active Comparator: 2
    Hydralazine
    Intervention: Drug: Hydralazine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
January 2009
January 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00607477
15386B
No
Not Provided
Not Provided
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Michael Maitland, M.D., Ph.D. University of Chicago
University of Chicago
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP