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

• ClinicalTrials.gov Identifier: NCT00607477
• Recruitment Status: Terminated
• First Posted: February 5, 2008
• Results First Posted: February 16, 2011
• Last Update Posted: June 10, 2014
• Sponsor: University of Chicago
• Information provided by (Responsible Party): University of Chicago

Tracking Information

• First Submitted Date: January 22, 2008
• First Posted Date: February 5, 2008
• Results First Submitted Date: November 22, 2010
• Results First Posted Date: February 16, 2011
• Last Update Posted Date: June 10, 2014
• Study Start Date: January 2008
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 14, 2013): Magnitude of Change in Blood Pressure [ Time Frame: 21 days ]
• Original Primary Outcome Measures (submitted: January 22, 2008): Time to and Magnitude of Change in Blood Pressure [ Time Frame: 21 days ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Treatment Induced Hypertension

Intervention

• 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

• Active Comparator: 1
  Minoxidil
  Intervention: Drug: Minoxidil
• Active Comparator: 2
  Hydralazine
  Intervention: Drug: Hydralazine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 12, 2009): 2
• Original Estimated Enrollment (submitted: January 22, 2008): 20
• Actual Study Completion Date: January 2009
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00607477
• Other Study ID Numbers: 15386B
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Chicago
• Study Sponsor: University of Chicago
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Chicago
• Verification Date: June 2014