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

September 15, 2010 updated by: Xijing Hospital

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 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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Dept. Resp. Diseases, Xijing Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Taxotere
  • Endostar
Active Comparator: 2
Drug: Treated by docetaxel and cisplatin
docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.
Other Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mean survival time
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
objective response rate
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Collaborators

Yantai Medgenn Ltd.

Investigators

  • Principal Investigator: Changgui Wu, MD, PHD, Dept. Resp. Diseases, Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

April 1, 2009

Study Registration Dates

First Submitted

April 9, 2008

First Submitted That Met QC Criteria

April 11, 2008

First Posted (Estimate)

April 14, 2008

Study Record Updates

Last Update Posted (Estimate)

September 17, 2010

Last Update Submitted That Met QC Criteria

September 15, 2010

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJ-EnXS0802

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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