Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases
Conditions
Brain Metastases
Conditions: official terms
Brain Neoplasms - Neoplasm Metastasis
Conditions: Keywords
Endostar, Radiotherapy, Brain Metastases
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: 6MV-X ray Type: Radiation
Name: Endostar Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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 Criteria:

- 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
Location
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Status: Recruiting
Contact: Xiaodong Jiang, MD - 0518-85605120
Start Date
June 2011
Completion Date
June 2013
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Source
Jiangsu Simcere Pharmaceutical Co., Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page