Back to resultsImpact of Endostar Combined With Chemotherapy on the Angiogenesis of Advanced Non-small Cell Lung Cancer (NSCLC)
Primary Purpose
Lung Neoplasms
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Treated by endostar combined with docetaxel and cisplatin
Treated by docetaxel and cisplatin
Sponsored by
About this trial
This is an interventional screening trial for Lung Neoplasms focused on measuring Lung Neoplasms, Endostatins, Vascular Endothelial Growth Factors, Fibroblast Growth Factors, Survival Rate
Eligibility 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.
Sites / Locations
- Dept. Resp. Diseases, Xijing HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
mean survival time
Secondary Outcome Measures
objective response rate
Full Information
NCT ID
NCT00657423
First Posted
April 9, 2008
Last Updated
September 15, 2010
Sponsor
Xijing Hospital
Collaborators
Yantai Medgenn Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00657423
Brief Title
Impact of Endostar Combined With Chemotherapy on the Angiogenesis of Advanced Non-small Cell Lung Cancer (NSCLC)
Official Title
Study of Endostar Combined With Docetaxel and Cisplatin on the Angiogenesis of Advanced Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
April 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Xijing Hospital
Collaborators
Yantai Medgenn Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
Keywords
Lung Neoplasms, Endostatins, Vascular Endothelial Growth Factors, Fibroblast Growth Factors, Survival Rate
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Treated by endostar combined with docetaxel and cisplatin
Other Intervention Name(s)
Endostar, Taxotere
Intervention Description
recombinant human endostatin given intravenously,7.5mg/㎡,d1-14,2cycles. docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.
Intervention Type
Drug
Intervention Name(s)
Treated by docetaxel and cisplatin
Other Intervention Name(s)
Taxotere
Intervention Description
docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.
Primary Outcome Measure Information:
Title
mean survival time
Time Frame
1 year
Secondary Outcome Measure Information:
Title
objective response rate
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengqing Li, MD, PHD
Phone
086-029-84771132
Email
shengqingli@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changgui Wu, MD, PHD
Organizational Affiliation
Dept. Resp. Diseases, Xijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. Resp. Diseases, Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengqing Li, MD. PHD.
Phone
086-029-84771132
Email
shengqingli@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Impact of Endostar Combined With Chemotherapy on the Angiogenesis of Advanced Non-small Cell Lung Cancer (NSCLC)
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