Status:
UNKNOWN
Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborating Sponsors:
The First People's Hospital of Lianyungang
Conditions:
Brain Metastases
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The aim of this study is to evaluate the clinical efficacy and safety of continuous Endostar infusion combined with radiotherapy for treatment of brain metastases.
Eligibility Criteria
Inclusion
- Histologically confirmed malignancy with presence of intraparenchymal brain metastases
- Karnofsky performance status ≥ 40
- Measurable disease according to RECIST criteria
- Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L
- Renal function: Cr ≤ 2.0×ULN
- Hepatic function: BIL ≤ 2.0×ULN, ALT/AST ≤ 5.0×ULN
- Adequate cardiac function
- Life expectancy ≥ 3 months
Exclusion
- Evidence of bleeding diathesis or serious infection
- Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
- Uncontrollable mental and nervous disorders
- Pregnant or lactating women
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01410370
Start Date
June 1 2011
End Date
June 1 2013
Last Update
April 24 2013
Active Locations (1)
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1
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China, 222002