Clinical trial NCT00657423: Impact of Endostar Combined With Chemotherapy on the Angiogenesis of Advanced Non-small Cell Lung Cancer (NSCLC)
Official title: Study of Endostar Combined With Docetaxel and Cisplatin on the Angiogenesis of Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lung Neoplasms
Keywords: Lung Neoplasms
Endostatins
Vascular Endothelial Growth Factors
Fibroblast Growth Factors
Survival Rate
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Yantai Medgenn Ltd.
First posted: 2008-04-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: mean survival time
timeFrame: 1 year
Secondary outcomes:
measure: objective response rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Dept. Resp. Diseases, Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Dept. Resp. Diseases, Xijing Hospital
name: Changgui Wu, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: