Know Cancer

forgot password

A Study of the Pharmacodynamic Effects of Anti-Vascular Endothelial Growth

21 Years
Open (Enrolling)
Hypertension, Proteinuria

Thank you

Trial Information

A Study of the Pharmacodynamic Effects of Anti-Vascular Endothelial Growth

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, we 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.

Inclusion Criteria:

- 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:

- none

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Effect of VEGF on endothelial function and on retinal microvasculature and the pulmonary function of patients with malignancy (primary or secondary) involving the lung.

Safety Issue:


Principal Investigator

Ross Andrew Soo, MBBS, MRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

August 2007

Completion Date:

Related Keywords:

  • Hypertension
  • Proteinuria
  • Hypertension
  • Proteinuria