Small Cell Lung Cancer
Conditions
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).
Interventions
DRUGEndostar
Endostar® 7.5mg/m2 on day 1 to day 14
DRUGEtoposide-Carboplatin
Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.
Sponsors
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) | Oct-30-2012 |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate (CBR) | Oct-30-2012 |
| Response duration | Oct-30-2012 |
| Time to progression(TTP) | Oct-30-2012 |
| Objective response rate (ORR) | Oct-30-2012 |
| Progression free survival | at 6 months |
| Overall survival (OS) | Oct-30-2012 |
| Quality of life (QOL) | Oct-30-2012 |
Countries
China
Outcome results
None listed