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A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC) (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01028729
Recruitment Status : Unknown
Verified December 2009 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was:  Recruiting
First Posted : December 9, 2009
Last Update Posted : December 9, 2009
Sponsor:
Information provided by:
Simcere Pharmaceutical Co., Ltd

Tracking Information
First Submitted Date  ICMJE December 7, 2009
First Posted Date  ICMJE December 9, 2009
Last Update Posted Date December 9, 2009
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2009)
Progression Free Survival (PFS) [ Time Frame: July 2011 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2009)
  • Objective Response Rate (ORR) [ Time Frame: July 2011 ]
  • Clinical Benefit Response (CBR) [ Time Frame: July 2011 ]
  • Overall Survival (OS) [ Time Frame: July 2011 ]
  • Survival Rate [ Time Frame: one year ]
  • Adverse Events [ Time Frame: July 2011 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer (NSCLC)
Intervention  ICMJE
  • Drug: Endostar
    7.5mg/m2/day, iv, from day 1 to day 14
    Other Name: Recombinant Human Endostatin Injection
  • Drug: Gemcitabine-Cisplatin chemotherapy
    Gemcitabine 1000 mg/m2, iv, on day 1, 8 Cisplatin 80mg/m2, iv, on day 1, 2, 3
    Other Name: GP chemotherapy
Study Arms  ICMJE Experimental: Endostar with chemotherapy
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.
Interventions:
  • Drug: Endostar
  • Drug: Gemcitabine-Cisplatin chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 8, 2009)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2011
Estimated Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01028729
Other Study ID Numbers  ICMJE SIM090801
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jinsheng Ren, Simcere Pharmaceutical Co., Ltd
Study Sponsor  ICMJE Simcere Pharmaceutical Co., Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yiping Zhang, Dr. Zhejiang Cancer Hospital
PRS Account Simcere Pharmaceutical Co., Ltd
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP