Back to resultsEndostar Continued Pumping Into Vein Combining With Gemcitabine-Carboplatin to Treat Non-Small Cell Lung Cancer (NSCLC)
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Gemcitabine,Carboplatin,Endostar
Gemcitabine(G) Carboplatin(C) Endostar
Gemcitabine(G) Carboplatin(C)
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small cell lung cancer, Endostar, Continued Pumping into, Gemcitabine, Carboplatin
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically diagnosed NSCLC;
- primary treatment,inoperable stage III/IV NSCLC;
- Age of 18-70years; Gender Not Required;
Adequate hematologic, renal, and hepatic function ,Specific index as follows:
liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10^9/l, ANC≥2.0×10^9/l platelet count ≥100×10^9/l, Hb≥100 g/l;
- ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;
- The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI);
- No history of serious drug allergy;
- Informed consent should be obtained before treatment.
Exclusion Criteria:
- Symptomatic brain metastases with cognitive disorder,bone metastases with complications;
- Major organ dysfunction and Serious Heart Disease( congestive heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease, myocardial infarct and Resistant hypertension,);
- Serious complications and investigator consider it is unsuited enrolling;
- Pregnant or lactating women;
- Allergic to research drug;
- participating in other experimental trials and receive the treatment in four weeks;
- The position that is for observing curative effect have a radiotherapy.
Sites / Locations
- HuNan province tumor hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Endostar -Continued Pumping into+GC
Endostar -injecting into +GC
GC
Arm Description
Endostar that is Continued Pumping into vein Combining With Gemcitabine -Carboplatin
Endostar that is injecting into vein with Gemcitabine -Carboplatin
Gemcitabine -Carboplatin
Outcomes
Primary Outcome Measures
Progression free survival (PFS)
Secondary Outcome Measures
Overall survival (OS)
Clinical benefit rate (CBR)
The level change of CECs,VEGF,TSP-1,VEGFR,P1GF,MVD in blood.
adverse reaction
Time to progression(TTP)
Full Information
NCT ID
NCT01549093
First Posted
February 27, 2012
Last Updated
March 22, 2015
Sponsor
Hunan Province Tumor Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01549093
Brief Title
Endostar Continued Pumping Into Vein Combining With Gemcitabine-Carboplatin to Treat Non-Small Cell Lung Cancer (NSCLC)
Official Title
A Randomized, Open Label, Controlled Study About Endostar Continued Pumping or Injecting Into Vein Combining With Gemcitabine-Carboplatin Versus Gemcitabine-Carboplatin Alone to Treat Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunan Province Tumor Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether Endostar with Gemcitabine-Carboplatin are more effective than Gemcitabine-Carboplatin alone in the treatment of Non-Small Cell Lung Cancer (NSCLC),and about Endostar ,Compared with intravenous, Continued vein-pumping maby is a more effective way.
Detailed Description
Endostar have anti-tumor activity by against vascular endothelial growth factor for initial treatment. This study was designed to evaluate the safety and efficacy of Endostar Continued vein-pumping Combining with Gemcitabine-Carboplatin (GC)chemotherapy in patients with NSCLC,and seeking for more effective injection.
Methods:
In this randomized, open label, 90 patients are planned to be enrolled at random into 3 arms(1:1:1): Experimental: Endostar -Continued Pumping into+Gemcitabine-Carboplatin(GC),Active Comparator: Endostar -injecting into +Gemcitabine-Carboplatin(GC),Active Comparator: Gemcitabine-Carboplatin(GC),
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Non-small cell lung cancer, Endostar, Continued Pumping into, Gemcitabine, Carboplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endostar -Continued Pumping into+GC
Arm Type
Experimental
Arm Description
Endostar that is Continued Pumping into vein Combining With Gemcitabine -Carboplatin
Arm Title
Endostar -injecting into +GC
Arm Type
Active Comparator
Arm Description
Endostar that is injecting into vein with Gemcitabine -Carboplatin
Arm Title
GC
Arm Type
Active Comparator
Arm Description
Gemcitabine -Carboplatin
Intervention Type
Drug
Intervention Name(s)
Gemcitabine,Carboplatin,Endostar
Intervention Description
Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 48hours and the dosage is 7.5mg/m2*2 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-6cycles.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine(G) Carboplatin(C) Endostar
Intervention Description
Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; Endostar:7.5 mg/m2 injecting into vein for 4 hours with saline on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle.Continued using 2-6cycles
Intervention Type
Drug
Intervention Name(s)
Gemcitabine(G) Carboplatin(C)
Intervention Description
Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; 21 days is one cycle.Continued using 2-6cycles
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Time Frame
two years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
two years
Title
Clinical benefit rate (CBR)
Time Frame
two years
Title
The level change of CECs,VEGF,TSP-1,VEGFR,P1GF,MVD in blood.
Time Frame
two years
Title
adverse reaction
Time Frame
two years
Title
Time to progression(TTP)
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically diagnosed NSCLC;
primary treatment,inoperable stage III/IV NSCLC;
Age of 18-70years; Gender Not Required;
Adequate hematologic, renal, and hepatic function ,Specific index as follows:
liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10^9/l, ANC≥2.0×10^9/l platelet count ≥100×10^9/l, Hb≥100 g/l;
ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;
The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI);
No history of serious drug allergy;
Informed consent should be obtained before treatment.
Exclusion Criteria:
Symptomatic brain metastases with cognitive disorder,bone metastases with complications;
Major organ dysfunction and Serious Heart Disease( congestive heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease, myocardial infarct and Resistant hypertension,);
Serious complications and investigator consider it is unsuited enrolling;
Pregnant or lactating women;
Allergic to research drug;
participating in other experimental trials and receive the treatment in four weeks;
The position that is for observing curative effect have a radiotherapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhua Chen, master
Phone
0086-731-89762221
Email
cjh_1000@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhua Chen, master
Organizational Affiliation
Hunan Province Tumor Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
HuNan province tumor hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Chen, master
Phone
0086-731-89762221
Email
cjh_1000@163.com
First Name & Middle Initial & Last Name & Degree
Jianhua Chen, master
12. IPD Sharing Statement
Learn more about this trial
Endostar Continued Pumping Into Vein Combining With Gemcitabine-Carboplatin to Treat Non-Small Cell Lung Cancer (NSCLC)
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