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

Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00912392
• Other study ID #: SIM-69
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2009
• Last updated: August 31, 2014
• Start date: May 2009
• Est. completion date: December 2012

Study information

• Verified date: August 2014
• Source: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Endostar
Endostar® 7.5mg/m2 on day 1 to day 14
• Etoposide-Carboplatin
Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)		Oct-30-2012	Yes
Secondary	Progression free survival		at 6 months	Yes
Secondary	Overall survival (OS)		Oct-30-2012	Yes
Secondary	Objective response rate (ORR)		Oct-30-2012	Yes
Secondary	Clinical benefit rate (CBR)		Oct-30-2012	Yes
Secondary	Response duration		Oct-30-2012	Yes
Secondary	Time to progression(TTP)		Oct-30-2012	Yes
Secondary	Quality of life (QOL)		Oct-30-2012	Yes