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A Study of the Pharmacodynamic Effects of Anti-Vascular Endothelial Growth Factor Therapy in Patients With Advanced Malignancies

This study has been completed.
Information provided by:
National University Hospital, Singapore Identifier:
First received: June 19, 2008
Last updated: April 8, 2010
Last verified: April 2010
The well-established role of vascular endothelial growth factor (VEGF) in carcinogenesis and tumor angiogenesis has led to the development of agents that target this pathway. Anti-VEGF agents the VEGF monoclonal antibody bevacizumab, and the small molecule VEGF receptor tyrosine kinase inhibitors. Angiogenic factors play a key role in the maintenance of lung integrity and normal endothelial function. Endothelial dysfunction has been implicated in hypertension, proteinuria and retinopathy. One of the major issues of anti-VEGF agents is its long-term toxicity especially taking into account the lack of adequate knowledge in this area and the possibility of prolonged periods of therapy in non-progressing patients. Hypertension and proteinuria are commonly seen in patients treated with anti-VEGF agents. In addition, the investigators have also observed in a relatively high frequency of pulmonary air-filled lesions in patients with malignancy in the lung treated with an anti-VEGF agent. Objectives of this exploratory study are to 1) determine the effect of anti-vascular endothelial growth factor (VEGF) on endothelial function 2) determine endothelial dysfunction as a marker of early response and as an indicator for the development of hypertension and proteinuria 3) characterize the effect of anti-VEGF therapy on the pulmonary function of patients with malignancy (primary or secondary) involving the lung in patients treated with anti-VEGF agents. Pharmacodynamic endpoints to be assessed are: blood pressure, brachial artery reactivity, retinal microvessels, microalbuminuria and proteinuria, pulmonary function, assess the effects of anti-VEGF therapy by assessing brachial artery reactivity, retinal vasculature and pulmonary function in a subset of patients receiving anti-VEGF therapy. The development of markers of endothelial dysfunction may result in the early identification of patients who are non-responders or develop toxicity from anti-VEGF treatment.

Advanced Malignancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of the Pharmacodynamic Effects of Anti-vascular Endothelial Growth Factor Therapy in Patients With Advanced Malignancies

Further study details as provided by National University Hospital, Singapore:

Study Start Date: September 2009

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This study aims to assess the pharmacodynamic effects of anti-VEGF therapy. The following groups of patients will be approached:

Those who are starting on anti-VEGF therapy (such as but not limited to bevacizumab, sunitinib, and sorafenib) as part of routine clinical management or on clinical studies


Inclusion Criteria:

  • Eligibility
  • Patients who are receiving single agent anti-VEGF therapy
  • Signed written informed consent
  • Patients with measurable pulmonary malignancy (primary or metastatic) as determined by RECIST will undergo assessment of pulmonary function
  • Patients with a known allergy to intravenous contrast used in fluorescein and indocyanine green angiography will be exempt from these investigations but will undergo other study assessments

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00978926

National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
  More Information

Responsible Party: Ross Andrew Soo, National University Hospital, Singapore Identifier: NCT00978926     History of Changes
Other Study ID Numbers: MC02/15/07
Study First Received: June 19, 2008
Last Updated: April 8, 2010

Keywords provided by National University Hospital, Singapore:
Anti-Vascular Endothelial growth factor

Additional relevant MeSH terms:
Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017