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Intrapleural Administration of Bevacizumab Versus Endostar for Pleural Effusions in NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02005120
Recruitment Status : Unknown
Verified December 2013 by Qiong Zhao, Zhejiang University.
Recruitment status was:  Recruiting
First Posted : December 9, 2013
Last Update Posted : December 20, 2013
Information provided by (Responsible Party):
Qiong Zhao, Zhejiang University

Brief Summary:
Malignant pleural effusion (MPE) is a common complication of advanced non-small cell lung cancer (NSCLC). Bevacizumab, a humanized monoclonal antibody against vascular endothelial growth factor (VEGF), has been shown to be efficient in suppressing the accumulation of pleural fluid. The other widely used treatment for MPE is recombinant human endostatin.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Bevacizumab Drug: recombinant human endostatin Phase 2

Detailed Description:
We designed this clinical trial to determine the efficacy and Safety of intrapleural Bevacizumab versus recombinant human endostatin as a treatment for malignant pleural effusions (MPE) in patients with non-small cell lung cancer (NSCLC).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Intrapleural Administration of Bevacizumab Versus Recombinant Human Endostatin (Endostar) for Refractory Malignant Pleural Effusions in Advanced Non-small Cell Lung Cancer (NSCLC)
Study Start Date : December 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Arm A
Drug: Bevacizumab
Intrapleural administration of bevacizumab
Other Name: Avastin

Experimental: Arm B
recombinant human endostatin
Drug: recombinant human endostatin
Intrapleural administration of recombinant human endostatin
Other Name: Endostar

Primary Outcome Measures :
  1. overall response rate (ORR) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. progression free survival (PFS) [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Quality of life [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patient who was confirmed stage IV NSCLC with malignant pleural effusion confirmed by cytology.

Males or females aged ≥18 years, < 75 years. Eastern Cooperative Oncology Group (ECOG) performance status 0-3. Life expectancy ≥12 weeks. Ability to maintain a drainage catheter. Previous intrapleural administration of chemotherapeutic drugs (preferred bleomycin) Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.

Adequate bone marrow, renal, and liver function are required. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.

Exclusion Criteria:

Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).

Active thoracic cavity or systemic bleeding. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0.

Female subjects should not be pregnant or breast-feeding. Known sensitivity to Bevacizumab or Endostar. Patients must not be on therapeutic anticoagulation with warfarin, heparin or low molecular weight heparin.

Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.

Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function :Total bilirubin £ 1.5 x upper limit of normal (ULN) and Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.

Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

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 identifier (NCT number): NCT02005120

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Contact: Qiong Zhao, PhD 0571-87236802

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China, Zhejiang
Qiong Zhao Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Qiong Zhao, PhD    0571-87236802   
Principal Investigator: Qiong Zhao, PhD         
The first affiliated hospital, Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Qiong Zhao, PhD    0571-87236802   
Principal Investigator: Qiong Zhao, PhD         
Sponsors and Collaborators
Zhejiang University
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Principal Investigator: Qiong Zhao, PhD The First Affiliated Hospital, Zhejiang University
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Responsible Party: Qiong Zhao, Chief of Department of Thoracic Oncology, Zhejiang University Identifier: NCT02005120    
Other Study ID Numbers: ZhejiangUniv
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: December 20, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pleural Effusion
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pleural Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors