Efficacy and Safety of Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion

February 3, 2014 updated by: Xiaofei Li, Tang-Du Hospital

Efficacy and Safety of Intrapleural Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion, A Randomized, Multicenter Study

Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background： Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients.

Methods:

A unblended, randomized study to compare the inhibition of two treatment methods in malignant pleural effusion. Consecutive 183 patients were randomly assigned to two groups, A group is Bevacizumab200mg by intrapleural administration; B group is injected pulvis talci with closed thoracic drainage.

Study Type

Interventional

Enrollment (Anticipated)

183

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Recruiting
        • Tangdu Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnose malignant pleural effusions by:

    • Diagnose malignant pleural neoplasms by histopathology
    • Recurrent pleural effusion, Histologically or cytologically confirmed diagnosis of cancer
  2. Written informed consent

Exclusion Criteria:

  1. <18years of age
  2. Expected survival <3 months
  3. Chest infection, chylothorax, pleurodesis or ipsilateral lung surgery once
  4. Planned chemotherapy
  5. Pregnancy or breast-feeding (women of child-bearing potential)
  6. Not signed informed consent or non-compliance with treatment protocols

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab
Bevacizumab200mg by intrapleural administration
Drug: Bevacizumab
Bevacizumab200mg by intrapleural administration
Other Names:
  • Avastin
Active Comparator: Pulvis talci
Pulvis talci 4g by intrapleural administration
Drug: Pulvis talci
Pulvis talci 4g by intrapleural administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in chest drainage
Time Frame: up to 3months
Observed chest drainage every day
up to 3months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the average daily VAS defining breathlessness
Time Frame: up to 1 year
VAS: Visual Analogue Scale
up to 1 year
Average daily thoracalgia assessed using VAS score
Time Frame: up to 1 year
VAS: Visual Analogue Scale
up to 1 year
percentage of adverse reactions
Time Frame: up to 1 year
up to 1 year
Length of Stay
Time Frame: up to 1 year
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

February 3, 2014

First Posted (Estimate)

February 4, 2014

Study Record Updates

Last Update Posted (Estimate)

February 4, 2014

Last Update Submitted That Met QC Criteria

February 3, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTSL002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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