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

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Non-small Cell Lung Cancer (NSCLC)	Drug: Endostar; Drug: Gemcitabine-Cisplatin chemotherapy	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	120 participants
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)
Study Start Date :	September 2009
Estimated Primary Completion Date :	July 2011
Estimated Study Completion Date :	August 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Objective Response Rate (ORR) [ Time Frame: July 2011 ]
2. Clinical Benefit Response (CBR) [ Time Frame: July 2011 ]
3. Overall Survival (OS) [ Time Frame: July 2011 ]
4. Survival Rate [ Time Frame: one year ]
5. Adverse Events [ Time Frame: July 2011 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Jinsheng Ren, Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:	NCT01028729 History of Changes
Other Study ID Numbers:	SIM090801
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