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

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ClinicalTrials.gov Identifier: NCT01028729
Recruitment Status : Unknown
Verified December 2009 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was:  Recruiting
First Posted : December 9, 2009
Last Update Posted : December 9, 2009
Sponsor:
Information provided by:
Simcere Pharmaceutical Co., Ltd

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gemcitabine

Arms and Interventions
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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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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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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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
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Contact: Yiping Zhang, Dr. 86-0571-88122188

Locations
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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
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Principal Investigator: Yiping Zhang, Dr. Zhejiang Cancer Hospital
More Information
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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    Key Record Dates
Last Update Posted: December 9, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
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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
Cisplatin
Gemcitabine
Endostar protein
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