Intrapleural Administration of Bevacizumab Versus Endostar for Pleural Effusions in NSCLC

NCT02005120 | Unknown Phase 2

• 1 other identifier: ZhejiangUniv
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• overall response rate (ORR)

  12 months

Secondary Outcomes (1)

• progression free survival (PFS)

  12 months

Other Outcomes (1)

• Quality of life

  12 months

Study Arms (2)

Arm A

EXPERIMENTAL

Bevacizumab

Drug: Bevacizumab

Arm B

EXPERIMENTAL

recombinant human endostatin

Drug: recombinant human endostatin

Interventions

Bevacizumab DRUG

Intrapleural administration of bevacizumab

Also known as: Avastin

Arm A

recombinant human endostatin DRUG

Intrapleural administration of recombinant human endostatin

Also known as: Endostar

Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (2)

Qiong Zhao

Hangzhou, Zhejiang, 310003, China

RECRUITING

The first affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Endostatins; endostar protein

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Officials

• Qiong Zhao, PhD

  The First Affiliated Hospital, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiong Zhao, PhD

CONTACT

0571-87236802; doczq.2008@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Thoracic Oncology

Study Record Dates

• First Submitted: November 24, 2013
• First Posted: December 9, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 20, 2013

Record last verified: 2013-12

Locations

CN (2)