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

• Sponsor: University of Chicago (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00607477
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Treatment Induced Hypertension	Drug: Minoxidil; Drug: Hydralazine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension With Direct Vasodilators, Minoxidil and Hydralazine
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Minoxidil	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
Active Comparator: 2 Hydralazine	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

Outcome Measures

Primary Outcome Measures

1. Magnitude of Change in Blood Pressure [21 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT00607477
• Other Study ID Numbers: 15386B
• First Posted: Feb 5, 2008
• Last Update Posted: Jun 10, 2014
• Last Verified: Jun 1, 2014

• Additional relevant MeSH terms: Hypertension; Minoxidil; Hydralazine

Study Results

Participant Flow

Arm/Group Title	Hydralazine	Minoxidil
Arm/Group Description	25 mg Hydralazine 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	2.5 mg Minoxidil 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
Period Title: Overall Study
STARTED	0	2
COMPLETED	0	2
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Hydralazine	Minoxidil	Total
Arm/Group Description	25 mg Hydralazine 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	2.5 mg Minoxidil 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	Total of all reporting groups
Overall Participants	0	2	2
Age (participants) [Number]
<=18 years	0 NaN	0 0%
Between 18 and 65 years	1 Infinity	1 50%
>=65 years	1 Infinity	1 50%
Gender (participants) [Number]
Female	1 Infinity	1 50%
Male	1 Infinity	1 50%
Region of Enrollment (participants) [Number]
United States	2 Infinity	2 100%

Outcome Measures

1. Primary Outcome

Title	Magnitude of Change in Blood Pressure
Time Frame	21 days

Outcome Measure Data

Analysis Population Description

No participants analyzed due to poor accrual and insufficient numbers of participants.

Arm/Group Title	Hydralazine	Minoxidil
Arm/Group Description	25 mg Hydralazine 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	2.5 mg Minoxidil 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
Measure Participants	0	0

Adverse Events

Time Frame	21 days
Arm/Group Title	Hydralazine		Minoxidil
Arm/Group Description	25 mg Hydralazine 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		2.5 mg Minoxidil 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
All Cause Mortality
	Hydralazine		Minoxidil
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Hydralazine		Minoxidil
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Hydralazine		Minoxidil
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		1/2 (50%)
Gastrointestinal disorders
diarrhea (grade 1)	0/0 (NaN)	0	1/2 (50%)	1

Limitations/Caveats

This study enrolled only 2 subjects and due to poor accrual, enrollment was stopped early. Due to the limited number of subjects available results cannot be assessed.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.