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

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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

Tracking Information
First Submitted Date  ICMJE January 22, 2008
First Posted Date  ICMJE February 5, 2008
Results First Submitted Date  ICMJE November 22, 2010
Results First Posted Date  ICMJE February 16, 2011
Last Update Posted Date June 10, 2014
Study Start Date  ICMJE January 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2013)
Magnitude of Change in Blood Pressure [ Time Frame: 21 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2008)
Time to and Magnitude of Change in Blood Pressure [ Time Frame: 21 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension
Official Title  ICMJE A Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension With Direct Vasodilators, Minoxidil and Hydralazine
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Treatment Induced Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    Minoxidil
    Intervention: Drug: Minoxidil
  • Active Comparator: 2
    Hydralazine
    Intervention: Drug: Hydralazine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 12, 2009)
2
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2008)
20
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00607477
Other Study ID Numbers  ICMJE 15386B
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Maitland, M.D., Ph.D. University of Chicago
PRS Account University of Chicago
Verification Date June 2014

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