Intrapleural Administration of Bevacizumab Versus Endostar for Pleural Effusions in NSCLC

Phase 2

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Bevacizumab; Drug: recombinant human endostatin

• Registration Number: NCT02005120
• Lead Sponsor: 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.

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).

Study Timeline

• Study First Submitted: 2013-11-24
• Status Verified: 2013-12
• Study Start: 2013-12
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-09
• Last Update Submitted: 2013-12-19
• Last Update Posted: 2013-12-20
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Bevacizumab	Bevacizumab
Arm B	recombinant human endostatin	recombinant human endostatin

Primary Outcome Measures

Name	Time	Method
overall response rate (ORR)	12 months

Secondary Outcome Measures

Name	Time	Method
progression free survival (PFS)	12 months

Trial Locations

Locations (2)

Qiong Zhao; 🇨🇳 Hangzhou, Zhejiang, China

The first affiliated hospital, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China