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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)

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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cancer Lung Cancer
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jinsheng Ren, Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01028729     History of Changes
Other Study ID Numbers: SIM090801
Study First Received: December 7, 2009
Last Updated: December 8, 2009
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Endostatins
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013