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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01028729
First received: December 7, 2009
Last updated: December 8, 2009
Last verified: December 2009

December 7, 2009
December 8, 2009
September 2009
July 2011   (final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: July 2011 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01028729 on ClinicalTrials.gov Archive Site
  • Objective Response Rate (ORR) [ Time Frame: July 2011 ] [ Designated as safety issue: No ]
  • Clinical Benefit Response (CBR) [ Time Frame: July 2011 ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: July 2011 ] [ Designated as safety issue: No ]
  • Survival Rate [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: July 2011 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)
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)

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).

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer (NSCLC)
  • 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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
August 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Yiping Zhang, Dr. 86-0571-88122188
China
 
NCT01028729
SIM090801
No
Jinsheng Ren, Simcere Pharmaceutical Co., Ltd
Simcere Pharmaceutical Co., Ltd
Not Provided
Principal Investigator: Yiping Zhang, Dr. Zhejiang Cancer Hospital
Simcere Pharmaceutical Co., Ltd
December 2009

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