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

NCT ID: NCT01661790

Last Updated: 2015-03-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-10-31

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).

Detailed Description

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Conditions

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Malignant Pleural Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bevacizumab & Cisplatin

Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Bevacizumab300mg\&Cispltin30mg by intrapleural administration of each 2 week

Cisplatin

Intervention Type DRUG

Cisplatin 30mg,intrapleural administration,each 2 week

Cisplatin

Cisplatin 30mg by intrapleural given every two weeks

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

Cisplatin 30mg,intrapleural administration,each 2 week

Interventions

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Bevacizumab

Bevacizumab300mg\&Cispltin30mg by intrapleural administration of each 2 week

Intervention Type DRUG

Cisplatin

Cisplatin 30mg,intrapleural administration,each 2 week

Intervention Type DRUG

Other Intervention Names

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Avastin

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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DuNan

director of oncology department in PLA 304 hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nan Du

Role: PRINCIPAL_INVESTIGATOR

PLA 304 hospital

Locations

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PLA 304 hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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PLA304DN-001

Identifier Type: -

Identifier Source: org_study_id

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