Pilot Study of the Treatment of 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”

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Time to and Magnitude of Change in Blood Pressure
  • Time Frame: 21 days
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Chicago Other

Overall Clinical Trial Officials and Contacts

Michael Maitland, M.D. Principal Investigator University of Chicago  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00607477

Study ID Number: UCIRB 15386B

ClinicalTrials.gov Identifier: NCT00607477

Health Authority: United States: Institutional Review Board