Intrapleural Bevacizumab and Cisplatin Therapy for Malignant Pleural Effusion Caused by Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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To determine the efficacy and Safety of intrapleural Bevacizumab and cisplatin as a treatment for malignant pleural effusions (MPE) in patients with non-small cell lung cancer (NSCLC).

Official Title
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Open-labeled, Randomized, Multicenter Phase III Study of Adjuvant Chemotherapy Comparing Bevacizumab Plus Cisplatin With Cisplatin Regimen in Malignant Pleural Effusion of Advanced Stage Non-Small-Cell Lung Cancer Patients

Conditions
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Malignant Pleural Effusion

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with advanced recurrent or progressive NSCLC proven cytohistologically Karnofsky performance status (KPS) ≥60 Life expectancy ≥ 2 months No history of severe diseases of major organs including liver, heart, and kidney No previous intrapleural therapy Written informed consent Exclusion Criteria: Active thoracic cavity or systemic bleeding Active pleural or systemic infection. Known sensitivity to Bevacizumab or Cisplatin Refusal to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab & Cisplatin<br>Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks | Drug: Bevacizumab<br>* Bevacizumab300mg&Cispltin30mg by intrapleural administration of each 2 week<br>* Other names: Avastin;Drug: Cisplatin<br>* Cisplatin 30mg,intrapleural administration,each 2 week<br>|
| Active Comparator: Cisplatin<br>Cisplatin 30mg by intrapleural given every two weeks | Drug: Cisplatin<br>* Cisplatin 30mg,intrapleural administration,each 2 week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complete Response and Partial Response | Response assessed by type-B ultrasonic tests; Complete remission (CR) was considered when the accumulated fluid had disappeared and was stable for at least four weeks; partial remission (PR) was considered when >50% of the accumulated fluid had disappeared, symptoms had improved, and the remaining fluid had failed to increase for at least four weeks; The total efficiency ORR was calculated by taking the sum of CR+PR | from randomization, This treatment was given every two weeks,responses were made by biweekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Progression Free Survival (PFS) |  | baseline to biweekly,until disease progression | 
| Overall Survival (OS) |  | randomization to four weeks,until death | 
| Adverse Reactions |  | Up to 1 month after the last treatment | 
| Qualify of Life (QoL) |  | baseline to biweekly,until death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bevacizumab;, non-small cell lung cancer;, malignant pleural effusion;, intrapleural administration