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

NCT ID: NCT00912392

Last Updated: 2014-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-12-31

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).

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Endostar

Intervention Type: DRUG

Endostar® 7.5mg/m2 on day 1 to day 14

Etoposide-Carboplatin

Intervention Type: DRUG

Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.

Etoposide-Carboplatin

Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.

Group Type: ACTIVE_COMPARATOR

Etoposide-Carboplatin

Intervention Type: DRUG

Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.

Interventions

Endostar

Endostar® 7.5mg/m2 on day 1 to day 14

Intervention Type: DRUG

Etoposide-Carboplatin

Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.

Intervention Type: DRUG

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shun Lu, Dr.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Locations

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SIM-69

Identifier Type: -

Identifier Source: org_study_id