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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Small Cell Lung Cancer

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Trial Information

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


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).


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;

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS)

Outcome Time Frame:

Oct-30-2012

Safety Issue:

Yes

Principal Investigator

Shun Lu, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shanghai Chest Hospital

Authority:

China: Ethics Committee

Study ID:

SIM-69

NCT ID:

NCT00912392

Start Date:

May 2009

Completion Date:

June 2013

Related Keywords:

  • Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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