Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Biomarker/Laboratory analysis, Treatment Active 18 to 75 Other XJ-EnXS0802 NCT00657423

Trial Description

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).

Further Study Information

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Xijing Hospital of the Fourth Military Medical University

Changgui Wu, MD, PHD

Principal Investigator

Shengqing Li, MD, PHD		Ph: 086-029-84771132
		Email: shengqingli@gmail.com

China
	Xi'an
	Xijing Hospital of the Fourth Military Medical University
		Shengqing Li, MD. PHD.	Ph: 086-029-84771132
			Email: shengqingli@gmail.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00657423
Information obtained from ClinicalTrials.gov on August 05, 2008