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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
• Treatments: Carboplatin; Endostar protein; Etoposide; Etoposide phosphate

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;