NCT00912392

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2009-06-03
• Last updated: 2014-09-03

Locations

1 site across 1 country: China