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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

Sponsor:

ClinicalTrials.gov Identifier:

NCT01028729

First Posted: December 9, 2009

Last Update Posted: December 9, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Simcere Pharmaceutical Co., Ltd

Purpose

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).

Condition	Intervention	Phase
Non-small Cell Lung Cancer (NSCLC)	Drug: Endostar Drug: Gemcitabine-Cisplatin chemotherapy	Phase 4


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	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)

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Gemcitabine

U.S. FDA Resources

Further study details as provided by Simcere Pharmaceutical Co., Ltd:

Primary Outcome Measures:

Progression Free Survival (PFS) [ Time Frame: July 2011 ]

Secondary Outcome Measures:

Objective Response Rate (ORR) [ Time Frame: July 2011 ]
Clinical Benefit Response (CBR) [ Time Frame: July 2011 ]
Overall Survival (OS) [ Time Frame: July 2011 ]
Survival Rate [ Time Frame: one year ]
Adverse Events [ Time Frame: July 2011 ]


Estimated Enrollment:	120
Study Start Date:	September 2009
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Endostar with chemotherapy 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.	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

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028729

Contacts


Contact: Yiping Zhang, Dr.	86-0571-88122188

Locations


China, Zhejiang
Zhejiang Cancer Hospital	Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Yiping Zhang, Dr. 86-0571-88122188

Sponsors and Collaborators

Simcere Pharmaceutical Co., Ltd

Investigators


Principal Investigator:	Yiping Zhang, Dr.	Zhejiang Cancer Hospital

More Information


Responsible Party:	Jinsheng Ren, Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:	NCT01028729 History of Changes
Other Study ID Numbers:	SIM090801
First Submitted:	December 7, 2009
First Posted:	December 9, 2009
Last Update Posted:	December 9, 2009
Last Verified:	December 2009

Additional relevant MeSH terms:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine Cisplatin Endostatins Antineoplastic Agents	Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors

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