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

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: NCT00912392
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Endostar Drug: Etoposide-Carboplatin Phase 2

Detailed Description:

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.
Active Comparator: Etoposide-Carboplatin
Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.
 Drug: Etoposide-Carboplatin
Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: Oct-30-2012 ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: at 6 months ]
  2. Overall survival (OS) [ Time Frame: Oct-30-2012 ]
  3. Objective response rate (ORR) [ Time Frame: Oct-30-2012 ]
  4. Clinical benefit rate (CBR) [ Time Frame: Oct-30-2012 ]
  5. Response duration [ Time Frame: Oct-30-2012 ]
  6. Time to progression(TTP) [ Time Frame: Oct-30-2012 ]
  7. Quality of life (QOL) [ Time Frame: Oct-30-2012 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912392


Locations
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China, Shanghai
Shanghai Chest Hospital
Shanghai, Shanghai, China, 200039
Sponsors and Collaborators
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Investigators
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Principal Investigator: Shun Lu, Dr. Shanghai Chest Hospital
More Information
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Responsible Party: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT00912392    
Other Study ID Numbers: SIM-69
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Etoposide
 Endostar protein
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors