Bevacizumab and Endothelium Dependent Vasodilation
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ClinicalTrials.gov Identifier: NCT01125943 |
Recruitment Status :
Completed
First Posted : May 19, 2010
Last Update Posted : January 10, 2013
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The introduction of angiogenesis inhibitors has remarkably improved treatment of patients with several types of cancer. One of the most reported side effects of angiogenesis inhibitors is hypertension. In patients treated with bevacizumab, a monoclonal antibody against vascular endothelial growth factor, hypertension had an overall incidence up to 32%. The increase in blood pressure occurs early in treatment. The etiology of hypertension caused by treatment with angiogenesis inhibitors is unclear. Understanding the pathogenesis of this side effect is essential for optimal treatment with this class of drugs.
The primary objective is to explore the effect of bevacizumab infusion on endothelium-dependent vasodilation of forearm resistance arteries.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension Cancer Endothelial Dysfunction | Drug: Acetylcholine Drug: Nitroprusside Drug: Bevacizumab | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Official Title: | Bevacizumab and Endothelium Dependent Vasodilation |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | November 2011 |

Arm | Intervention/treatment |
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Experimental: Acetylcholine
Intra-arterial infusion of acetylcholine in two increasing dosages during 5 minutes each during the intra-arterial infusion of bevacizumab
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Drug: Acetylcholine
Intra-arterial infusion Drug: Bevacizumab Intra arterial infusion |
Experimental: Nitroprusside
Infusion of two increasing dosages of nitroprusside during 5 minutes each during the continuous infusion of bevacizumab
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Drug: Nitroprusside
Intra arterial infusion Drug: Bevacizumab Intra arterial infusion |
- Vasomotor response assessed by venous occlusion strain gauge plethysmography [ Time Frame: 15 minutes ]Response to infusion of bevacizumab and/or acetylcholin or nitroprusside

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 18-50 years old
- Male
- Results of serum glucose, lipids and creatinine should be within the laboratory's reference ranges.
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
Exclusion Criteria:
- Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- History of or current abuse of drugs, alcohol or solvents.
- History of malignant disease.
- First degree relatives with a history of cancer before the age of 50
- First degree relatives with a history of premature cardiovascular disease before the age of 50
- Current use of medication.
- Clinical evidence of cardiac or pulmonary disease
- Hypertension ( systole >140mmHG, diastole >90mmHg)
- Diabetes mellitus
- Smoking
- Any clinically relevant abnormality on ECG.
- A history of thrombosis or first degree family members with a history of recurrent thrombosis
- Inability to understand the nature and extent of the trial and the procedures required.
- Previous participation in a study with bevacizumab

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125943
Netherlands | |
Radboud University Nijmegen Medical Centre | |
Nijmegen, Netherlands |
Responsible Party: | G. Rongen, Prof dr. G. Rongen, Radboud University Medical Center |
ClinicalTrials.gov Identifier: | NCT01125943 |
Other Study ID Numbers: |
BVZAch |
First Posted: | May 19, 2010 Key Record Dates |
Last Update Posted: | January 10, 2013 |
Last Verified: | January 2013 |
Hypertension Vascular Diseases Cardiovascular Diseases Bevacizumab Nitroprusside Acetylcholine Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents |
Growth Substances Physiological Effects of Drugs Growth Inhibitors Antihypertensive Agents Vasodilator Agents Nitric Oxide Donors Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents |