Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer (NSCLC)

Phase 2

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Endostar; Drug: Vinorelbine; Drug: Cisplatin; Radiation: Radiotherapy

• Registration Number: NCT01687439
• Lead Sponsor: Fudan University

Brief Summary

Primary objective: functional imaging and quantitative imaging detection of the effects of Endostar combined with chemotherapy and radiotherapy on Non-small Cell Lung Cancer (NSCLC).

Secondary objective: To evaluate 1) the role of Endostar in regulating tumor vessels and normalizing of microenvironment; 2) Toxicity of Endostar combined with chemotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2012-08-16
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-18
• Last Update Submitted: 2012-09-18
• Study First Posted: 2012-09-19
• Last Update Posted: 2012-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Histologically or cytologically proven inoperable stage IIIb-IV NSCLC
• ECOG PS 0-1
• Life expectancy > 3 months
• Adequate blood functions: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin ≥ 9 g / dL
• Adequate liver function: total bilirubin <1.5 times the upper limit of normal (ULN); AST and ALT <2.5 times ULN in patients without liver metastases, <5 times ULN in patients with liver metastases
• Adequate renal function: serum creatinine ≤ 1.25 times ULN or calculated creatinine clearance ≥ 50 mL / min and urinary protein <2+. In patients with baseline urinary protein ≥ 2+, 24 hours urine should be collected and 24 hours urine protein ≤ 1g
• International normalized ratio (INR) ≤ 1.5 and prothrombin time(PT) ≤ 1.5 times ULN within 7 days before enrollment
• Written informed consent

Exclusion Criteria

• Evidence of bleeding diathesis or coagulopathy
• History of hemoptysis, defined as bright red blood more than half a teaspoon 3 months before enrollment
• Previously received chemotherapy and radiotherapy and biological targeted therapy
• Uncontrolled hypertension (systolic blood pressure> 150 mmHg and/or diastolic blood pressure> 100 mm Hg)
• Clinically significant (ie, active) cardiovascular diseases, such as cerebrovascular accident (within 6 months before initiating treatment), myocardial infarction (within 6 months before initiating treatment), unstable angina, congestive heart failure (New York Heart Association class ≥Grade II) , serious arrhythmia which needs medication during the study and may affect the study or can not be controlled by drugs
• Unhealed wounds, active peptic ulcer or fracture
• Gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before enrollment
• Women with intact uterus (menopause more than two years excluded) who are unwilling to take effective non-hormonal contraception (IUD, spermicide barrier birth control device or sterilization) during the study. Male who are unwilling to take effective contraceptive measures during the study
• Participated in other clinical trials within 28 days before the initiation of treatment.
• Allergic to any of the study drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Vinorelbine	Eligible patients receive one cycle of Endostar monotherapy, two cycles of Endostar combined with chemotherapy (vinorelbine plus cisplatin) treatment, followed by Endostar plus radiotherapy treatment.
Treatment	Radiotherapy	Eligible patients receive one cycle of Endostar monotherapy, two cycles of Endostar combined with chemotherapy (vinorelbine plus cisplatin) treatment, followed by Endostar plus radiotherapy treatment.
Treatment	Endostar	Eligible patients receive one cycle of Endostar monotherapy, two cycles of Endostar combined with chemotherapy (vinorelbine plus cisplatin) treatment, followed by Endostar plus radiotherapy treatment.
Treatment	Cisplatin	Eligible patients receive one cycle of Endostar monotherapy, two cycles of Endostar combined with chemotherapy (vinorelbine plus cisplatin) treatment, followed by Endostar plus radiotherapy treatment.

Primary Outcome Measures

Name	Time	Method
Tumor blood volume	3 months
Tumor blood flow	3 months
Permeability-surface area product	3 months
18-FDG PET SUV values	3 months

Secondary Outcome Measures

Name	Time	Method
The incidence of adverse events	3 months

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China