Impact of Endostar Combined With Chemotherapy on the Angiogenesis of Advanced Non-small Cell Lung Cancer (NSCLC)
NCT ID: NCT00657423
Last Updated: 2010-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
80 participants
INTERVENTIONAL
2008-04-30
2009-04-30
Brief Summary
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* 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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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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1
Treated by endostar combined with docetaxel and cisplatin
recombinant human endostatin given intravenously,7.5mg/㎡,d1-14,2cycles. docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.
2
Treated by docetaxel and cisplatin
docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.
Interventions
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Treated by endostar combined with docetaxel and cisplatin
recombinant human endostatin given intravenously,7.5mg/㎡,d1-14,2cycles. docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.
Treated by docetaxel and cisplatin
docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Yantai Medgenn Ltd.
INDUSTRY
Xijing Hospital
OTHER
Responsible Party
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Dept.of Respiratory Diseases, Xijing Hospital
Principal Investigators
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Changgui Wu, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Dept. Resp. Diseases, Xijing Hospital
Locations
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Dept. Resp. Diseases, Xijing Hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XJ-EnXS0802
Identifier Type: -
Identifier Source: org_study_id