Impact of Endostar Combined With Chemotherapy on the Angiogenesis of Advanced Non-small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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To study the impact of endostar combined with docetaxel and cisplatin on the angiogenesis of non-small cell lung cancer, patients will be randomly assigned to the group one (endostar combined with docetaxel and cisplatin) and group two (docetaxel and cisplatin). The serum concentrations of Endostatin,VEGF and bFGF are determined. Blood circulating endothelial cells (CECs) and circulating hematopoietic progenitor cells (CPCs) will be measured by flow cytometer. Statistical analysis will be applied to study the relationship between the levels of Endostatin, VEGF, bFGF, CECs and CPCs and the clinical outcomes such as objective response rate(ORT), time to progression (TTP), mean survival time(MST), toxicity and quality of life (QOL).

Detailed Description
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To study the impact of endostar combined with docetaxel and cisplatin on the angiogenesis of non-small cell lung cancer,patients will be randomly assigned to the experimental group(endostar combined with docetaxel and cisplatin) and the control group (docetaxel and cisplatin). the serum concentrations of Endostatin,VEGF and bFGF are determined. Blood circulating endothelial cells (CECs) and circulating hematopoietic progenitor cells (CPCs) will be measured by flow cytometer. the clinical parameters such as objective response rate (ORT),time to progression(TTP) and mean survival time(MST) will be collected according to the WHO criteria. the toxicity will be recorded according to the NCI-CTC v3.0. the Quality of life was self-assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire. Statistical analysis will be applied to study the relationship between the levels of Endostatin,VEGF,bFGF,CECs and CPCs and the clinical outcomes such as ORT, TTP, MST, toxicity and QOL.

Official Title
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Study of Endostar Combined With Docetaxel and Cisplatin on the Angiogenesis of Advanced Non-small Cell Lung Cancer

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Drug: Treated by endostar combined with docetaxel and cisplatin
* Drug: Treated by docetaxel and cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of advanced or metastatic NSCLC (confirmed histologically, with a tumor that was measurable by clinical and/or radiologic examination. Have an Eastern Cooperative Oncology Group performance status 0 to 2. Adequate renal, cardiac, hepatic, and hematologic function as indicated by the following parameters: absolute neutrophil count 2 x the ninth power of ten/L, thrombocytes 100 x the ninth power of ten/L, hemoglobin 10 g/dL, total bilirubin 1.25x the upper limit of normal range (ULN), ALT and AST 1.5x ULN, alkaline phosphatase 5x ULN, creatinine 1.15x ULN. Exclusion Criteria: Known brain metastases or secondary neoplasia. Myocardial insufficiency or myocardial infarction within the preceding 6 months. Severe renal or hepatic insufficiency. Pre-existing motor or sensor neurotoxicity WHO grade 2. Severe psychologic disease. Active infection, or other condition that could compromise protocol compliance. Simultaneous administration of other antineoplastic medications. Clinically significant hemoptysis. Pregnancy and/or lactation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Treated by endostar combined with docetaxel and cisplatin<br>* recombinant human endostatin given intravenously,7.5mg/㎡,d1-14,2cycles. docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.<br>* Other names: Taxotere;|
| Active Comparator: 2<br> | Drug: Treated by docetaxel and cisplatin<br>* docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.<br>* Other names: Taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean survival time |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Neoplasms, Endostatins, Vascular Endothelial Growth Factors, Fibroblast Growth Factors, Survival Rate