Intrapleural Bevacizumab After Pleural Drainage in the Context of Breast Cancer
Status:
Terminated
Trial end date:
2017-10-17
Target enrollment:
Participant gender:
Summary
Metastatic pleural effusion is a common complication of late-stage cancer and reduces the
quality of life and survival of patients. The survival of patients with recurrent pleurisy by
uncontrolled local or systemic treatment is less than 6 months. It is important to develop
specific therapies to improve the quality of life and survival of patients with metastatic
pleurisy.
Bevacizumab is a monoclonal anti vascular endothelial growth factor (VEGF) which has proven
effective in many indications in oncology. Vascular endothelial growth factor (VEGF) is an
angiogenic factor which increases endothelial permeability. It plays a central role in many
tumors of epithelial origin. In this context, it is legitimate to ask whether an
antiangiogenic targeting VEGF may be effective in patients with metastatic pleurisy by
decreasing local blood supply and over-permeability.
No study has been interested in the intra-pleural pharmacokinetics of monoclonal antibodies
and there are no predictive or prognostic biomarkers for metastatic pleural effusions.
The investigators believe that intrapleural administration of bevacizumab will reduce the
pleural vasculature permeability. It will neutralize VEGF present in pleural fluid and reduce
the replenishment of effusion due to its prolonged half-life of 21 days.
The investigators therefore propose a phase I study to determine the maximum tolerated dose
and the recommended dose for phases II, studying the pharmacokinetics of intrapleural
bevacizumab administered by an implantable device after evacuating a symptomatic metastatic
pleurisy as part of a mammary carcinoma. The VEGF intrapleural levels and serum will be study
and the time until a new puncture. Dyspnea will be evaluated as well as its impact on quality
of life.