Intrapleural Bevacizumab Injection for Malignant Effusion in Lung Cancer

NCT02054052 | Completed Phase 2 DMC

• 1 other identifier: GZTO1401
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Malignant pleural or pericardial effusion is common in lung cancer, and intrapleural drugs injection is important in the treatment. Non- cytotoxic drugs include those with a sclerosing effect that produces pleurodesis, which is easy to cause severe chest pain despite of no influence on the following chemotherapy. Tumor angiogenesis is important in producing MPE. Bevacizumab has been administrated locally in treating optic nerve sickness successfully by anti-VEGF mechanism. So we hypothesize that intrapleural bevacizumab is also effective in treating MPE.

Conditions

Non-small Cell Lung Cancer; Malignant Pleural Effusion

Keywords

non-small cell lung cancer; malignant pleural effusion; bevacizumab; intrapleural injection; pericardial effusion

Outcome Measures

Primary Outcomes (1)

• Lung cancer symptom

  Evaluated by lung cancer symptom scale 21-30 days after the treatment

Secondary Outcomes (4)

• response rate

  Evaluate response rate 21-30 days after the treatment

• Time to progression

  1 year after the treatment of MPE.

• Overall survival

  1 year after the treatment of MPE

• Number of Participants with Adverse Events

  one months after the treatment of MPE

Study Arms (1)

Bevacizumab

EXPERIMENTAL

Bevacizumab 100 mg, intrapleural injection treating maliganant pleural or percardial effusion

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

Bevacizumab 100 mg, intrapleural injection treating MPE after the drainage of MPE

Also known as: Avastin

Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Histological or cytological diagnosis of non-small cell lung cancer.
• Cytological diagnosis of malignant pleural or pericardial effusion (MPE)
• Symptomatic MPE evaluated by researchers
• Unsuitable for or reject systemic therapy of tumor
• Estimated survival of more than 3 months. 6.18 years or older

You may not qualify if:

• Current or recent (within 10 days prior to treatment) use the full amount of inhibition of platelet function, anticoagulants or thrombolytic therapy, which allows prophylactic anticoagulants
• Be allergic to bevacizumab
• Pregnant or lactating woman
• Pleural or pericardial infection

Sponsors & Collaborators

• Haihong Yang, MD, Pricipal investigator: lead

Study Sites (1)

The First Affliliated Hospital of Guangzhou MC

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Pleural Effusion, Malignant; Pericardial Effusion

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pleural Neoplasms; Pleural Effusion; Pleural Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Haihong Yang, MD

  the First Affiliated Hospital of Guangzhou MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: February 4, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 29, 2019

Record last verified: 2019-03

Locations

CN (1)