Clinical trial NCT00912392: Etoposide-Carboplatin Alone or With Endostar for Extensive Disease Small Cell Lung Cancer (ED-SCLC)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Lead sponsor: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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;

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: Oct-30-2012
Secondary outcomes:
measure: Progression free survival
timeFrame: at 6 months
measure: Overall survival (OS)
timeFrame: Oct-30-2012
measure: Objective response rate (ORR)
timeFrame: Oct-30-2012
measure: Clinical benefit rate (CBR)
timeFrame: Oct-30-2012
measure: Response duration
timeFrame: Oct-30-2012
measure: Time to progression(TTP)
timeFrame: Oct-30-2012
measure: Quality of life (QOL)
timeFrame: Oct-30-2012
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Shun Lu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: