Intrapleural Bevacizumab After Pleural Drainage in the Context of Breast Cancer (BEVAP)
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|ClinicalTrials.gov Identifier: NCT02250118|
Recruitment Status : Terminated (Insufficient Recruitment)
First Posted : September 26, 2014
Last Update Posted : November 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pleural Effusion, Malignant Breast Cancer||Drug: Bevacizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study to Determine the Maximum Tolerated Dose and Evaluate the Pharmacokinetics of Intrapleural Bevacizumab After Pleural Drainage in Patients With Symptomatic Malignant Pleural Effusion in the Context of Breast Cancer|
|Actual Study Start Date :||December 9, 2014|
|Actual Primary Completion Date :||April 12, 2017|
|Actual Study Completion Date :||October 17, 2017|
Intrapleural use: range 0.5 - 5 mg/kg
Other Name: Avastin
- To determine the maximum tolerated dose (MTD) [ Time Frame: 90 days after intrapleural injection ]Maximum tolerated dose (MTD) according to safety of intrapleural bevacizumab at dose levels of 1 mg/kg, 3 mg/kg and 5 mg/kg administered by pleural catheter after drainage of symptomatic malignant pleural effusion in a context of breast cancer.
- Study of the pleural and serum pharmacokinetics [ Time Frame: 90 days ]Pharmacokinetics of bevacizumab just before administration and 1 hour after treatment on Day 1, and at D15, D30, D60 and D90.
- Study of pleural and serum Vascular Endothelial Growth Factor (VEGF) levels [ Time Frame: 90 days ]Pleural and serum VEGF levels just before administration and 1 hour after treatment on Day 1, and at D15, D30, D60 and D90.
- Determination of time until new punction or death [ Time Frame: 2 years ]Response to treatment assessed by the time to new puncture
- Total number of pleural drainage procedures [ Time Frame: 90 days ]Measure of the total number of pleural drainage procedures at D15, D30, D60 and D90.
- Drainage-free survival and overall survival [ Time Frame: 2 years ]Drainage-free survival and overall survival Evaluation of survival without punction and overall survival
- Evaluation of dyspnoea [ Time Frame: 90 days ]Measure by dyspnoea scale and peak flow at D15, D30, D60 and D90
- Evaluation of quality of life [ Time Frame: 2 years ]Quality of life (QLQ-C30) questionnaire according to European Organisation for Research and Treatment of Cancer (EORTC) and FACIT questionnaire Dyspnoea 10 Short Form at D15, D30, D60 and D90 and every 6 month during 2 years
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): NCT02250118
|Institut Curie - Hôpital René Huguenin|
|Saint-Cloud, France, 92210|
|Principal Investigator:||Maya Gutierrez, MD||Institut Curie - Hôpital René Huguenin|