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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Endostar
* Drug: Etoposide-Carboplatin


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etoposide-Carboplatin with Endostar<br>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. | Drug: Endostar<br>* Endostar® 7.5mg/m2 on day 1 to day 14<br>Drug: Etoposide-Carboplatin<br>* Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.<br>|
| Active Comparator: Etoposide-Carboplatin<br>Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1. | Drug: Etoposide-Carboplatin<br>* Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) |  | Oct-30-2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | at 6 months | 
| Overall survival (OS) |  | Oct-30-2012 | 
| Objective response rate (ORR) |  | Oct-30-2012 | 
| Clinical benefit rate (CBR) |  | Oct-30-2012 | 
| Response duration |  | Oct-30-2012 | 
| Time to progression(TTP) |  | Oct-30-2012 | 
| Quality of life (QOL) |  | Oct-30-2012 |