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

Sponsor

Xijing Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00657423

Collaborator

Yantai Medgenn Ltd. (Industry)

Enrollment

Location

Arms

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms	Drug: Treated by endostar combined with docetaxel and cisplatin Drug: Treated by docetaxel and cisplatin	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Study Start Date :

Apr 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2008

Anticipated Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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. Other Names: Endostar Taxotere
Active Comparator: 2	Drug: Treated by docetaxel and cisplatin docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles. Other Names: Taxotere

Arm

Intervention/Treatment

Experimental: 1

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.

Other Names:

Endostar

Taxotere

Active Comparator: 2

Drug: Treated by docetaxel and cisplatin

docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.

Other Names:

Taxotere

Outcome Measures

Primary Outcome Measures

mean survival time [1 year]

Secondary Outcome Measures

objective response rate [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.