Bevacizumab and Endothelium Dependent Vasodilation
This study has been completed.
Sponsor:
Radboud University
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
G. Rongen, Radboud University
ClinicalTrials.gov Identifier:
NCT01125943
First received: May 17, 2010
Last updated: January 8, 2013
Last verified: January 2013
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Purpose
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 | Intervention |
|---|---|
|
Hypertension Cancer Endothelial Dysfunction |
Drug: Acetylcholine Drug: Nitroprusside Drug: Bevacizumab |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Bevacizumab and Endothelium Dependent Vasodilation |
Resource links provided by NLM:
Drug Information available for:
Acetylcholine chloride
Sodium nitroprusside
Nitroprusside
Bevacizumab
U.S. FDA Resources
Further study details as provided by Radboud University:
Primary Outcome Measures:
- Vasomotor response assessed by venous occlusion strain gauge plethysmography [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]Response to infusion of bevacizumab and/or acetylcholin or nitroprusside
| Enrollment: | 24 |
| Study Start Date: | June 2010 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Acetylcholine
Intra-arterial infusion of acetylcholine in two increasing dosages during 5 minutes each during the intra-arterial infusion of bevacizumab
|
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
|
Drug: Nitroprusside
Intra arterial infusion
Drug: Bevacizumab
Intra arterial infusion
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | G. Rongen, Prof dr. G. Rongen, Radboud University |
| ClinicalTrials.gov Identifier: | NCT01125943 History of Changes |
| Other Study ID Numbers: | BVZAch |
| Study First Received: | May 17, 2010 |
| Last Updated: | January 8, 2013 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Acetylcholine Nitroprusside Bevacizumab Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Cholinergic Agonists |
Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nitric Oxide Donors Antihypertensive Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013