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

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: Malignant Pleural Effusion
• Intervention / Treatment: Drug: Bevacizumab; Drug: Pulvis talci

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

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Recruiting
      • Tangdu Hospital
      • Contact: qiang lu, doctor; Phone Number: 18092920605; Email: luqiang@fmmu.edu.cn

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Observed chest drainage every day	up to 3months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

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: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: CTSL002