Treatment Induced Hypertension
Conditions
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.
Interventions
DRUGMinoxidil
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
DRUGHydralazine
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
Sponsors
University of Chicago
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Magnitude of Change in Blood Pressure | 21 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hydralazine 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 | 0 |
| Minoxidil 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 | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Minoxidil | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants |
| Age, Categorical >=65 years | 1 participants | 1 participants |
| Age, Categorical Between 18 and 65 years | 1 participants | 1 participants |
| Gender Female | 1 participants | 1 participants |
| Gender Male | 1 participants | 1 participants |
| Region of Enrollment United States | 2 participants | 2 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 1 / 2 |
| serious Total, serious adverse events | 0 / 0 | 0 / 2 |
Outcome results
Primary
Magnitude of Change in Blood Pressure
Time frame: 21 days
Population: No participants analyzed due to poor accrual and insufficient numbers of participants.