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

Air Force Military Medical University of People's Liberation Army

Status and phase

Unknown

Phase 3

Conditions

Lung Neoplasms

Treatments

Drug: Treated by docetaxel and cisplatin

Drug: Treated by endostar combined with docetaxel and cisplatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00657423

XJ-EnXS0802

Details and patient eligibility

About

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).

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.