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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Xijing Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Yantai Medgenn Ltd.
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT00657423
First received: April 9, 2008
Last updated: September 15, 2010
Last verified: August 2008
  Purpose

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 Intervention Phase
Lung Neoplasms
Drug: Treated by endostar combined with docetaxel and cisplatin
Drug: Treated by docetaxel and cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • mean survival time [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • objective response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Taxotere

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657423

Contacts
Contact: Shengqing Li, MD, PHD 086-029-84771132 shengqingli@gmail.com

Locations
China, Shaanxi
Dept. Resp. Diseases, Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Shengqing Li, MD. PHD.    086-029-84771132    shengqingli@gmail.com   
Sponsors and Collaborators
Xijing Hospital
Yantai Medgenn Ltd.
Investigators
Principal Investigator: Changgui Wu, MD, PHD Dept. Resp. Diseases, Xijing Hospital
  More Information

No publications provided

Responsible Party: Shengqing Li, Dept.of Respiratory Diseases, Xijing Hospital
ClinicalTrials.gov Identifier: NCT00657423     History of Changes
Other Study ID Numbers: XJ-EnXS0802
Study First Received: April 9, 2008
Last Updated: September 15, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
Lung Neoplasms
Endostatins
Vascular Endothelial Growth Factors
Fibroblast Growth Factors
Survival Rate

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Neoplasms
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014