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

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ClinicalTrials.gov Identifier: NCT02054078
Recruitment Status : Unknown
Verified February 2014 by Xiaofei Li, Tang-Du Hospital.
Recruitment status was:  Recruiting
First Posted : February 4, 2014
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
Xiaofei Li, Tang-Du Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malignant Pleural Effusion Drug: Bevacizumab Drug: Pulvis talci Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Intrapleural Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion, A Randomized, Multicenter Study
Study Start Date : January 2012
Estimated Primary Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bevacizumab
Bevacizumab200mg by intrapleural administration
 Drug: Bevacizumab
Bevacizumab200mg by intrapleural administration
Other Name: Avastin
Active Comparator: Pulvis talci
Pulvis talci 4g by intrapleural administration
 Drug: Pulvis talci
Pulvis talci 4g by intrapleural administration


Outcome Measures
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Primary Outcome Measures :
  1. Changes in chest drainage [ Time Frame: up to 3months ]
    Observed chest drainage every day


Secondary Outcome Measures :
  1. the average daily VAS defining breathlessness [ Time Frame: up to 1 year ]
    VAS: Visual Analogue Scale

  2. Average daily thoracalgia assessed using VAS score [ Time Frame: up to 1 year ]
    VAS: Visual Analogue Scale

  3. percentage of adverse reactions [ Time Frame: up to 1 year ]
  4. Length of Stay [ Time Frame: up to 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02054078


Contacts
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Contact: xiaofei li, doctor 13909111010 lxfchest@fmmu.edu.cn

Locations
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China, Shaanxi
Tangdu Hospital Recruiting
Xi'an, Shaanxi, China
Contact: qiang lu, doctor    18092920605    luqiang@fmmu.edu.cn   
Sponsors and Collaborators
Tang-Du Hospital
More Information
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Responsible Party: Xiaofei Li, chief physician, Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02054078    
Other Study ID Numbers: CTSL002
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Pleural Effusion, Malignant
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors