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

Lung Neoplasms Clinical Trial

Official title:

Study of Endostar Combined With Docetaxel and Cisplatin on the Angiogenesis of Advanced Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00657423
• Other study ID #: XJ-EnXS0802
• Status: Recruiting
• Phase: Phase 3
• First received: April 9, 2008
• Last updated: September 15, 2010
• Start date: April 2008
• Est. completion date: April 2009

Study information

• Verified date: August 2008
• Source: Xijing Hospital
• Contact: Shengqing Li, MD, PHD
• Phone: 086-029-84771132
• Email: shengqingli[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• Treated 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.
• Treated by docetaxel and cisplatin
docetaxel given intravenously,75mg/?,d1,2cycles. cisplatin given intravenously,75mg/?,d1,2cycles.

Locations

Country	Name	City	State
China	Dept. Resp. Diseases, Xijing Hospital	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Xijing Hospital	Yantai Medgenn Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean survival time		1 year	No
Secondary	objective response rate		1 year	No