Intrapleural Administration of Bevacizumab Versus Endostar for Pleural Effusions in NSCLC

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Zhejiang University
Sponsor:
Information provided by (Responsible Party):
Qiong Zhao, Zhejiang University
ClinicalTrials.gov Identifier:
NCT02005120
First received: November 24, 2013
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Non Small Cell Lung Cancer
Drug: Bevacizumab
Drug: recombinant human endostatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Zhejiang University:

Primary Outcome Measures:
  • overall response rate (ORR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival (PFS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Bevacizumab
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005120

Contacts
Contact: Qiong Zhao, PhD 0571-87236802 doczq.2008@gmail.com

Locations
China, Zhejiang
The first affiliated hospital, Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Qiong Zhao, PhD    0571-87236802    doczq.2008@gmail.com   
Principal Investigator: Qiong Zhao, PhD         
Qiong Zhao Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Qiong Zhao, PhD    0571-87236802    doczq.2008@gmail.com   
Principal Investigator: Qiong Zhao, PhD         
Sponsors and Collaborators
Zhejiang University
Investigators
Principal Investigator: Qiong Zhao, PhD The first affiliated hospital, Zhejiang University
  More Information

No publications provided

Responsible Party: Qiong Zhao, Chief of Department of Thoracic Oncology, Zhejiang University
ClinicalTrials.gov Identifier: NCT02005120     History of Changes
Other Study ID Numbers: ZhejiangUniv
Study First Received: November 24, 2013
Last Updated: December 19, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Pleural Diseases
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pleural Effusion
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bevacizumab
Endostatins
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014