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Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin 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
Endostar -Continued Pumping into+GP
Endostar -injecting into +GP
Sponsored by
Beijing Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Endostar, advanced Non-small cell lung cancer, Continued Pumping into vein, Gemcitabine, Carboplatin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically or cytologically diagnosed NSCLC;
  2. primary treatment,inoperable stage IIIB/IV NSCLC;
  3. Age of 18-75years; Gender Not Required;

  4. 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;

  5. ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;
  6. 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);
  7. No history of serious drug allergy;
  8. Informed consent should be obtained before treatment.

Exclusion Criteria:

  1. Symptomatic brain metastases with cognitive disorder,bone metastases with complications;
  2. Major organ dysfunction and Serious Heart Disease( congestive heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease, myocardial infarct and Resistant hypertension,);
  3. Serious complications and investigator consider it is unsuited enrolling;
  4. Pregnant or lactating women;
  5. Allergic to research drug;
  6. participating in other experimental trials and receive the treatment in four weeks;
  7. The position that is for observing curative effect have a radiotherapy.

Sites / Locations

  • The Beijing Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endostar -Continued Pumping into+GP

Endostar -injecting into +GP

Arm Description

Endostar that is Continued Pumping into vein Combining With Gemcitabine -Cisplatin

Endostar that is injecting into vein with Gemcitabine -Cisplatin

Outcomes

Primary Outcome Measures

Progression free survival (PFS)

Secondary Outcome Measures

Overall survival (OS)
Clinical benefit rate (CBR)
Number of Participants With Adverse Events(AE) as a Measure of Safety and Tolerability

Full Information

First Posted
August 13, 2012
Last Updated
September 4, 2018
Sponsor
Beijing Chest Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01669707
Brief Title
Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)
Official Title
Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chest Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether Endostar pumping into vein with Gemcitabine-Cisplatin are more effective than Endostar with Gemcitabine-Cisplatin regularly in the treatment of Non-Small Cell Lung Cancer (NSCLC).
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-Cisplatin (GP)chemotherapy in patients with NSCLC,and seeking for more effective injection.

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
Endostar, advanced Non-small cell lung cancer, Continued Pumping into vein, Gemcitabine, Carboplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endostar -Continued Pumping into+GP
Arm Type
Experimental
Arm Description
Endostar that is Continued Pumping into vein Combining With Gemcitabine -Cisplatin
Arm Title
Endostar -injecting into +GP
Arm Type
Active Comparator
Arm Description
Endostar that is injecting into vein with Gemcitabine -Cisplatin
Intervention Type
Drug
Intervention Name(s)
Endostar -Continued Pumping into+GP
Intervention Description
Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 120 hours and the dosage is 7.5mg/m2*5 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-4cycles.
Intervention Type
Drug
Intervention Name(s)
Endostar -injecting into +GP
Intervention Description
Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg 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 2-4cycles
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
Number of Participants With Adverse Events(AE) as a Measure of Safety and Tolerability
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically diagnosed NSCLC; primary treatment,inoperable stage IIIB/IV NSCLC; Age of 18-75years; 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
Liyan Xu, MD
Email
xuliyan2009@yahoo.cn
Facility Information:
Facility Name
The Beijing Chest Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liyan Xu, MD
Email
xuliyan2009@yahoo.cn
First Name & Middle Initial & Last Name & Degree
Liyan Xu, MD

12. IPD Sharing Statement

Learn more about this trial

Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)

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