Intrapleural Bevacizumab Injection for Malignant Effusion in Lung Cancer

Intrapleural Bevacizumab Injection for Treating Malignant Pleural or Pericardial Effusion in Non-small Cell Lung Cancer

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer; Malignant Pleural Effusion
• Intervention / Treatment: Drug: Bevacizumab

Detailed Description

Inclusion Criteria:

1. Histological or cytological diagnosis of non-small cell lung cancer.
2. Cytological diagnosis of malignant pleural or pericardial effusion (MPE)
3. Symptomatic MPE evaluated by researchers
4. Unsuitable for or reject systemic therapy of tumor
5. Continuous TKI treatment after TKI-resistance
6. Estimated survival of more than 3 months. 7.18 years or older

Exclusion Criteria:

1. 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
2. Be allergic to bevacizumab
3. Pregnant or lactating woman
4. Pleural or pericardial infection

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • The First Affliliated Hospital of Guangzhou MC

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

Exclusion Criteria:

1. 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
2. Be allergic to bevacizumab
3. Pregnant or lactating woman
4. Pleural or pericardial infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bevacizumab; Bevacizumab 100 mg, intrapleural injection treating maliganant pleural or percardial effusion	Drug: Bevacizumab; Bevacizumab 100 mg, intrapleural injection treating MPE after the drainage of MPE; Other Names: Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lung cancer symptom	Evaluated by lung cancer symptom scale 21-30 days after the treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Haihong Yang, MD, Pricipal investigator
• Investigators: Principal Investigator: Haihong Yang, MD, The first affiliated hospital of Guangzhou MC

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: January 27, 2014
• First Submitted That Met QC Criteria: February 1, 2014
• First Posted (Estimate): February 4, 2014

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: bevacizumab; non-small cell lung cancer; malignant pleural effusion; intrapleural injection; pericardial effusion
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pleural Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pleural Effusion, Malignant; Pleural Effusion; Pericardial Effusion; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: GZTO1401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided