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

Simcere

Status and phase: Completed; Phase 2

Conditions: Small Cell Lung Cancer

Treatments: Drug: Endostar; Drug: Etoposide-Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00912392

SIM-69

Details and patient eligibility

About

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.

Full 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).

Enrollment: 138 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

Etoposide-Carboplatin with Endostar

Experimental group

Description:

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.

Treatment:

Drug: Endostar

Drug: Etoposide-Carboplatin

Etoposide-Carboplatin

Active Comparator group

Description:

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

Treatment:

Drug: Etoposide-Carboplatin