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Intrapleural Bevacizumab Injection for Malignant Effusion in Lung Cancer

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ClinicalTrials.gov Identifier: NCT02054052
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Haihong Yang, MD, Pricipal investigator, Guangzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Malignant Pleural Effusion Drug: Bevacizumab Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intrapleural Bevacizumab Injection for Treating Malignant Pleural or Pericardial Effusion in Non-small Cell Lung Cancer
Actual Study Start Date : January 2014
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

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 Name: Avastin




Primary Outcome Measures :
  1. Lung cancer symptom [ Time Frame: Evaluated by lung cancer symptom scale 21-30 days after the treatment ]

Secondary Outcome Measures :
  1. response rate [ Time Frame: Evaluate response rate 21-30 days after the treatment ]
  2. Time to progression [ Time Frame: 1 year after the treatment of MPE. ]
  3. Overall survival [ Time Frame: 1 year after the treatment of MPE ]
  4. Number of Participants with Adverse Events [ Time Frame: one months after the treatment of MPE ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054052


Locations
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China, Guangdong
The First Affliliated Hospital of Guangzhou MC
Guangzhou, Guangdong, China, 510120
Sponsors and Collaborators
Haihong Yang, MD, Pricipal investigator
Investigators
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Principal Investigator: Haihong Yang, MD the First Affiliated Hospital of Guangzhou MC

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Responsible Party: Haihong Yang, MD, Pricipal investigator, Deputy Chief Physician, Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT02054052    
Other Study ID Numbers: GZTO1401
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Haihong Yang, MD, Pricipal investigator, Guangzhou Medical University:
non-small cell lung cancer
malignant pleural effusion
bevacizumab
intrapleural injection
pericardial effusion
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pleural Effusion, Malignant
Pleural Effusion
Pericardial Effusion
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pleural Diseases
Pleural Neoplasms
Heart Diseases
Cardiovascular Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors