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:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00607477
First received: January 22, 2008
Last updated: June 3, 2014
Last verified: June 2014

January 22, 2008
June 3, 2014
January 2008
January 2009   (final data collection date for primary outcome measure)
Magnitude of Change in Blood Pressure [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Time to and Magnitude of Change in Blood Pressure [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00607477 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00607477
15386B
No
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