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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT00912392
First received: June 1, 2009
Last updated: August 31, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Small Cell Lung Cancer
Drug: Endostar
Drug: Etoposide-Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: Oct-30-2012 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
  • Overall survival (OS) [ Time Frame: Oct-30-2012 ] [ Designated as safety issue: Yes ]
  • Objective response rate (ORR) [ Time Frame: Oct-30-2012 ] [ Designated as safety issue: Yes ]
  • Clinical benefit rate (CBR) [ Time Frame: Oct-30-2012 ] [ Designated as safety issue: Yes ]
  • Response duration [ Time Frame: Oct-30-2012 ] [ Designated as safety issue: Yes ]
  • Time to progression(TTP) [ Time Frame: Oct-30-2012 ] [ Designated as safety issue: Yes ]
  • Quality of life (QOL) [ Time Frame: Oct-30-2012 ] [ Designated as safety issue: Yes ]

Enrollment: 138
Study Start Date: May 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912392

Locations
China, Shanghai
Shanghai Chest Hospital
Shanghai, Shanghai, China, 200039
Sponsors and Collaborators
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Investigators
Principal Investigator: Shun Lu, Dr. Shanghai Chest Hospital
  More Information

No publications provided

Responsible Party: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT00912392     History of Changes
Other Study ID Numbers: SIM-69
Study First Received: June 1, 2009
Last Updated: August 31, 2014
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Carboplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014