A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)
Conditions
Non-small Cell Lung Cancer (NSCLC)
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Interventional
Study Phase
Phase 4
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Endostar Type: Drug
Name: Gemcitabine-Cisplatin chemotherapy Type: Drug
Overall Status
Recruiting
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).
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Status: Recruiting
Contact: Yiping Zhang, Dr. - 86-0571-88122188
Start Date
September 2009
Completion Date
August 2011
Sponsors
Simcere Pharmaceutical Co., Ltd
Source
Simcere Pharmaceutical Co., Ltd
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page