A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)
NCT ID: NCT01028729
Last Updated: 2009-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2009-09-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Endostar
7.5mg/m2/day, iv, from day 1 to day 14
Gemcitabine-Cisplatin chemotherapy
Gemcitabine 1000 mg/m2, iv, on day 1, 8 Cisplatin 80mg/m2, iv, on day 1, 2, 3
Interventions
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Endostar
7.5mg/m2/day, iv, from day 1 to day 14
Gemcitabine-Cisplatin chemotherapy
Gemcitabine 1000 mg/m2, iv, on day 1, 8 Cisplatin 80mg/m2, iv, on day 1, 2, 3
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Simcere Pharmaceutical Co., Ltd
OTHER
Responsible Party
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Simcere Pharmaceutical Co., Ltd
Principal Investigators
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Yiping Zhang, Dr.
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Yiping Zhang, Dr.
Role: CONTACT
Phone: 86-0571-88122188
Facility Contacts
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Yiping Zhang, Dr.
Role: primary
Other Identifiers
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SIM090801
Identifier Type: -
Identifier Source: org_study_id