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

Phase 2

Completed

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: Etoposide-Carboplatin; Drug: Endostar

• Registration Number: NCT00912392
• Lead Sponsor: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd

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.

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 Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-31
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etoposide-Carboplatin	Etoposide-Carboplatin	Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.
Etoposide-Carboplatin with Endostar	Etoposide-Carboplatin	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.
Etoposide-Carboplatin with Endostar	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.

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	Oct-30-2012

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China