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Etoposide-Carboplatin Alone or With Endostar for Extensive Disease Small Cell Lung Cancer (ED-SCLC)

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ClinicalTrials.gov Identifier: NCT00912392
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):

June 1, 2009
June 3, 2009
September 3, 2014
May 2009
December 2012   (Final data collection date for primary outcome measure)
Progression free survival (PFS) [ Time Frame: Oct-30-2012 ]
Same as current
Complete list of historical versions of study NCT00912392 on ClinicalTrials.gov Archive Site
  • Progression free survival [ Time Frame: at 6 months ]
  • Overall survival (OS) [ Time Frame: Oct-30-2012 ]
  • Objective response rate (ORR) [ Time Frame: Oct-30-2012 ]
  • Clinical benefit rate (CBR) [ Time Frame: Oct-30-2012 ]
  • Response duration [ Time Frame: Oct-30-2012 ]
  • Time to progression(TTP) [ Time Frame: Oct-30-2012 ]
  • Quality of life (QOL) [ Time Frame: Oct-30-2012 ]
Same as current
Not Provided
Not Provided
 
Etoposide-Carboplatin Alone or With Endostar for Extensive Disease Small Cell Lung Cancer (ED-SCLC)
Etoposide-Carboplatin (EC) Versus EC Plus Endostar in Patients With Extensive Disease Small Cell Lung Cancer (ED-SCLC): Randomized, Open Label, Placebo-controlled, Multicentre Study

Background:

The effect of existing treatment modalities of extensive disease small-cell lung cancer (ED-SCLC) is unsatisfactory. Progress of new strategies including more efficient therapy is wanted. Endostar® (Rh-endostatin Injection) may 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® combined with etoposide-carboplatin (EC) chemotherapy in patients with ED-SCLC seeking for more effective treatment.

Methods:

In this randomized, open label, placebo-controlled, multicentre trial, 120 patients are planned to be enrolled at random into 2 arms(1:1) from 10 centers between June 2009 and June 2011. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University. Main eligibility criteria are histological or cytological diagnosis of ED-SCLC, with an age of 18-75 years. All eligible patients receive etoposide-carboplatin (EC) alone or with endostar® for 4-6 cycles (21 days for 1 cycle). In arm1 patients receive endostar® 7.5mg/m2 on day 1 to day 14, etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1. In arm2 patients receive etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.

Primary endpoint: progress free survival (PFS).

Secondary endpoint: progress free survival at 6 months, overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), Response duration, time to progression(TTP) and quality of life (QOL).

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Small Cell Lung Cancer
  • Drug: Endostar
    Endostar® 7.5mg/m2 on day 1 to day 14
  • Drug: Etoposide-Carboplatin
    Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.
  • Experimental: Etoposide-Carboplatin with Endostar
    Endostar® 7.5mg/m2 on day 1 to day 14, etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.
    Interventions:
    • Drug: Endostar
    • Drug: Etoposide-Carboplatin
  • Active Comparator: Etoposide-Carboplatin
    Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.
    Intervention: Drug: Etoposide-Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically diagnosed SCLC;
  • Age of 18-75 years;
  • Life expectancy > 3 months;
  • Adequate hematologic, renal, and hepatic function;
  • ECOG PS 0-2;

Exclusion Criteria:

  • Brain metastases;
  • Clinically significant cardiovascular disease;
  • Presence of hepatic and renal dysfunction;
  • Evidence of bleeding diathesis or coagulopathy
  • Pregnant or lactating woman;
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00912392
SIM-69
No
Not Provided
Not Provided
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Not Provided
Principal Investigator: Shun Lu, Dr. Shanghai Chest Hospital
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
August 2014

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