Lung Neoplasms
Conditions
Keywords
Lung Neoplasms, Endostatins, Vascular Endothelial Growth Factors, Fibroblast Growth Factors, Survival Rate
Brief summary
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
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.
Interventions
DRUGTreated 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.
DRUGTreated by docetaxel and cisplatin
docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.
Sponsors
Yantai Medgenn Ltd.
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean survival time | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate | 1 year |
Countries
China
Contacts
Primary ContactShengqing Li, MD, PHD
Outcome results
None listed