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

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

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.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: Endostar; Drug: Etoposide-Carboplatin

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).

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200039
      • Shanghai Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
• Investigators: Principal Investigator: Shun Lu, Dr., Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 1, 2009
• First Submitted That Met QC Criteria: June 2, 2009
• First Posted (Estimate): June 3, 2009

Study Record Updates

• Last Update Posted (Estimate): September 3, 2014
• Last Update Submitted That Met QC Criteria: August 31, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Carboplatin; Etoposide; Endostar protein
• Other Study ID Numbers: SIM-69