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

August 31, 2014 updated by: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200039
        • Shanghai Chest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS)
Time Frame: Oct-30-2012
Oct-30-2012

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: at 6 months
at 6 months
Overall survival (OS)
Time Frame: Oct-30-2012
Oct-30-2012
Objective response rate (ORR)
Time Frame: Oct-30-2012
Oct-30-2012
Clinical benefit rate (CBR)
Time Frame: Oct-30-2012
Oct-30-2012
Response duration
Time Frame: Oct-30-2012
Oct-30-2012
Time to progression(TTP)
Time Frame: Oct-30-2012
Oct-30-2012
Quality of life (QOL)
Time Frame: Oct-30-2012
Oct-30-2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd

Investigators

  • Principal Investigator: Shun Lu, Dr., Shanghai Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 1, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Estimate)

September 3, 2014

Last Update Submitted That Met QC Criteria

August 31, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIM-69

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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