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

Phase 3
18 Years
75 Years
Open (Enrolling)
Lung Neoplasms

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Trial Information

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

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

- 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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

mean survival time

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Changgui Wu, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. Resp. Diseases, Xijing Hospital


China: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

April 2009

Related Keywords:

  • Lung Neoplasms
  • Lung Neoplasms
  • Endostatins
  • Vascular Endothelial Growth Factors
  • Fibroblast Growth Factors
  • Survival Rate
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms