Back to resultsA Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC) (NSCLC)
Primary Purpose
Non-small Cell Lung Cancer (NSCLC)
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Endostar
Gemcitabine-Cisplatin chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer (NSCLC)
Eligibility Criteria
Inclusion Criteria:
- Histological or cytological diagnosis of inoperable stage IIIB/IV NSCLC
- At least one measurable lesion
- Age of 18-75 years
- Life expectancy > 3 months
- ECOG performance status 0-2
- Adequate hematologic, renal, and hepatic function
Exclusion Criteria:
- Prior systemic chemotherapy for NSCLC
- Evidence of any unstable diseases (serious infection, grade 4 hypertension, unstable angina, congestive heart-failure, compromised renal or hepatic function, nonhealing wound or bone fracture)
- Concurrent anticoagulation therapy
- Evidence of bleeding diathesis or coagulopathy
- Pregnant or lactating women
- Allergic to E.coli preparation
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endostar with chemotherapy
Arm Description
All eligible patients will receive Endostar in combination with Gemcitabine plus Platinum-based chemotherapy for 4 cycles (21 days for each cycle). Endostar treatment will continue after completion of chemotherapy cycles until disease progression.
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS)
Secondary Outcome Measures
Objective Response Rate (ORR)
Clinical Benefit Response (CBR)
Overall Survival (OS)
Survival Rate
Adverse Events
Full Information
NCT ID
NCT01028729
First Posted
December 7, 2009
Last Updated
December 8, 2009
Sponsor
Simcere Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01028729
Brief Title
A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)
Acronym
NSCLC
Official Title
A Study of Endostar in Combination With Chemotherapy Followed by Endostar Maintenance Therapy in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Simcere Pharmaceutical Co., Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This single arm study will assess the safety and efficacy of Endostar combined with chemotherapy (Gemcitabine plus Platinum-based chemotherapy) followed by Endostar maintenance therapy in patients with stage IIIB/IV non-small cell lung cancer (NSCLC).
Detailed Description
All eligible patients will receive Endostar in combination with Gemcitabine plus Platinum-based chemotherapy for 4 cycles (21 days for each cycle). Endostar treatment will continue after completion of chemotherapy cycles until disease progression. Efficacy will be evaluated every two cycles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer (NSCLC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endostar with chemotherapy
Arm Type
Experimental
Arm Description
All eligible patients will receive Endostar in combination with Gemcitabine plus Platinum-based chemotherapy for 4 cycles (21 days for each cycle). Endostar treatment will continue after completion of chemotherapy cycles until disease progression.
Intervention Type
Drug
Intervention Name(s)
Endostar
Other Intervention Name(s)
Recombinant Human Endostatin Injection
Intervention Description
7.5mg/m2/day, iv, from day 1 to day 14
Intervention Type
Drug
Intervention Name(s)
Gemcitabine-Cisplatin chemotherapy
Other Intervention Name(s)
GP chemotherapy
Intervention Description
Gemcitabine 1000 mg/m2, iv, on day 1, 8 Cisplatin 80mg/m2, iv, on day 1, 2, 3
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Time Frame
July 2011
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
July 2011
Title
Clinical Benefit Response (CBR)
Time Frame
July 2011
Title
Overall Survival (OS)
Time Frame
July 2011
Title
Survival Rate
Time Frame
one year
Title
Adverse Events
Time Frame
July 2011
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:
Histological or cytological diagnosis of inoperable stage IIIB/IV NSCLC
At least one measurable lesion
Age of 18-75 years
Life expectancy > 3 months
ECOG performance status 0-2
Adequate hematologic, renal, and hepatic function
Exclusion Criteria:
Prior systemic chemotherapy for NSCLC
Evidence of any unstable diseases (serious infection, grade 4 hypertension, unstable angina, congestive heart-failure, compromised renal or hepatic function, nonhealing wound or bone fracture)
Concurrent anticoagulation therapy
Evidence of bleeding diathesis or coagulopathy
Pregnant or lactating women
Allergic to E.coli preparation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yiping Zhang, Dr.
Phone
86-0571-88122188
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yiping Zhang, Dr.
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiping Zhang, Dr.
Phone
86-0571-88122188
12. IPD Sharing Statement
Learn more about this trial
A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)
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