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

NCT02054078 | Unknown Phase 2 DMC

• 1 other identifier: CTSL002
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• Changes in chest drainage

  Observed chest drainage every day

  up to 3months

Secondary Outcomes (4)

• the average daily VAS defining breathlessness

  up to 1 year

• Average daily thoracalgia assessed using VAS score

  up to 1 year

• percentage of adverse reactions

  up to 1 year

• Length of Stay

  up to 1 year

Study Arms (2)

Bevacizumab

EXPERIMENTAL

Bevacizumab200mg by intrapleural administration

Drug: Bevacizumab

Pulvis talci

ACTIVE COMPARATOR

Pulvis talci 4g by intrapleural administration

Drug: Pulvis talci

Interventions

Bevacizumab DRUG

Bevacizumab200mg by intrapleural administration

Also known as: Avastin

Bevacizumab

Pulvis talci DRUG

Pulvis talci 4g by intrapleural administration

Pulvis talci

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, China

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

xiaofei li, doctor

CONTACT

13909111010; lxfchest@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: February 4, 2014
• Study Start: January 1, 2012
• Primary Completion: March 1, 2014
• Last Updated: February 4, 2014

Record last verified: 2014-02

Locations

CN (1)