A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2009 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Simcere Pharmaceutical Co., Ltd

ClinicalTrials.gov Identifier:

NCT01028729

First received: December 7, 2009

Last updated: December 8, 2009

Last verified: December 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

December 7, 2009

Last Updated Date

December 8, 2009

Start Date ^ICMJE

September 2009

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Progression Free Survival (PFS) [ Time Frame: July 2011 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01028729 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Objective Response Rate (ORR) [ Time Frame: July 2011 ] [ Designated as safety issue: No ]
Clinical Benefit Response (CBR) [ Time Frame: July 2011 ] [ Designated as safety issue: No ]
Overall Survival (OS) [ Time Frame: July 2011 ] [ Designated as safety issue: No ]
Survival Rate [ Time Frame: one year ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: July 2011 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)

Official Title ^ICMJE

A Study of Endostar in Combination With Chemotherapy Followed by Endostar Maintenance Therapy in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)

Brief Summary

This single arm study will assess the safety and efficacy of Endostar combined with chemotherapy (Gemcitabine plus Platinum-based chemotherapy) followed by Endostar maintenance therapy in patients with stage IIIB/IV non-small cell lung cancer (NSCLC).

Detailed Description

All eligible patients will receive Endostar in combination with Gemcitabine plus Platinum-based chemotherapy for 4 cycles (21 days for each cycle). Endostar treatment will continue after completion of chemotherapy cycles until disease progression. Efficacy will be evaluated every two cycles.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Non-small Cell Lung Cancer (NSCLC)

Intervention ^ICMJE

Drug: Endostar
7.5mg/m2/day, iv, from day 1 to day 14

Other Name: Recombinant Human Endostatin Injection
Drug: Gemcitabine-Cisplatin chemotherapy
Gemcitabine 1000 mg/m2, iv, on day 1, 8 Cisplatin 80mg/m2, iv, on day 1, 2, 3

Other Name: GP chemotherapy

Study Arm (s)

Experimental: Endostar with chemotherapy

Interventions:

Drug: Endostar
Drug: Gemcitabine-Cisplatin chemotherapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

August 2011

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histological or cytological diagnosis of inoperable stage IIIB/IV NSCLC
At least one measurable lesion
Age of 18-75 years
Life expectancy > 3 months
ECOG performance status 0-2
Adequate hematologic, renal, and hepatic function

Exclusion Criteria:

Prior systemic chemotherapy for NSCLC
Evidence of any unstable diseases (serious infection, grade 4 hypertension, unstable angina, congestive heart-failure, compromised renal or hepatic function, nonhealing wound or bone fracture)
Concurrent anticoagulation therapy
Evidence of bleeding diathesis or coagulopathy
Pregnant or lactating women
Allergic to E.coli preparation

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yiping Zhang, Dr.

86-0571-88122188

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01028729

Other Study ID Numbers ^ICMJE

SIM090801

Has Data Monitoring Committee

Responsible Party

Jinsheng Ren, Simcere Pharmaceutical Co., Ltd

Study Sponsor ^ICMJE

Simcere Pharmaceutical Co., Ltd

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Yiping Zhang, Dr.

Zhejiang Cancer Hospital

Information Provided By

Simcere Pharmaceutical Co., Ltd

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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