Intrapleural Bevacizumab Injection for Malignant Effusion in Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02054052
• Other study ID #: GZTO1401
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Malignant Pleural Effusion
• Non-small Cell Lung Cancer
• Pericardial Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

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

Locations

Country	Name	City	State
China	The First Affliliated Hospital of Guangzhou MC	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Haihong Yang, MD, Pricipal investigator

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung cancer symptom		Evaluated by lung cancer symptom scale 21-30 days after the treatment
Secondary	response rate		Evaluate response rate 21-30 days after the treatment
Secondary	Time to progression		1 year after the treatment of MPE.
Secondary	Overall survival		1 year after the treatment of MPE
Secondary	Number of Participants with Adverse Events		one months after the treatment of MPE