Clinical trial NCT02054052: Intrapleural Bevacizumab Injection for Malignant Effusion in Lung Cancer
Official title: Intrapleural Bevacizumab Injection for Treating Malignant Pleural or Pericardial Effusion in Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Malignant Pleural Effusion
Keywords: non-small cell lung cancer
malignant pleural effusion
bevacizumab
intrapleural injection
pericardial effusion
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Lung cancer symptom
timeFrame: Evaluated by lung cancer symptom scale 21-30 days after the treatment
Secondary outcomes:
measure: response rate
timeFrame: Evaluate response rate 21-30 days after the treatment
measure: Time to progression
timeFrame: 1 year after the treatment of MPE.
measure: Overall survival
timeFrame: 1 year after the treatment of MPE
measure: Number of Participants with Adverse Events
timeFrame: one months after the treatment of MPE
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affliliated Hospital of Guangzhou MC
state: Guangdong
Study officials:
affiliation: the First Affiliated Hospital of Guangzhou MC
name: Haihong Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: