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

• Status: Unknown status
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Xijing Hospital
• Collaborator: Yantai Medgenn Ltd.
• Treatments: Cisplatin; Docetaxel; Endostar protein; Endostatins

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.