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

Treatment Induced Hypertension Clinical Trial

Official title:

A Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension With Direct Vasodilators, Minoxidil and Hydralazine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00607477
• Other study ID #: 15386B
• Status: Terminated
• Phase: N/A
• First received: January 22, 2008
• Last updated: June 3, 2014
• Start date: January 2008
• Est. completion date: January 2009

Study information

• Verified date: June 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• 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
• 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

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnitude of Change in Blood Pressure		21 days	No