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

December 8, 2009 updated by: Simcere Pharmaceutical Co., Ltd

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)

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • GP chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival (PFS)
Time Frame: July 2011
July 2011

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Simcere Pharmaceutical Co., Ltd

Investigators

  • Principal Investigator: Yiping Zhang, Dr., Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

July 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

December 7, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

December 9, 2009

Last Update Submitted That Met QC Criteria

December 8, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIM090801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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