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Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases

Primary Purpose

Brain Metastases

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
6MV-X ray
Endostar
Sponsored by
Jiangsu Simcere Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases focused on measuring Endostar, Radiotherapy, Brain Metastases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First People's Hospital of LianyungangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

treatment

control

Arm Description

Radiotherapy plus Endostar

Radiotherapy

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)

Secondary Outcome Measures

Overall Survival
Serum VEGF Levels
VEGF levels in tumor tissue
Incidence of Adverse Events
Cerebral Edema

Full Information

First Posted
July 20, 2011
Last Updated
April 22, 2013
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborators
The First People's Hospital of Lianyungang
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1. Study Identification

Unique Protocol Identification Number
NCT01410370
Brief Title
Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases
Official Title
Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy for the Treatment of Patients With Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborators
The First People's Hospital of Lianyungang

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
Endostar, Radiotherapy, Brain Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Description
Radiotherapy plus Endostar
Arm Title
control
Arm Type
Active Comparator
Arm Description
Radiotherapy
Intervention Type
Radiation
Intervention Name(s)
6MV-X ray
Intervention Description
3Gy/time, 5 times/week, a total of 10 times
Intervention Type
Drug
Intervention Name(s)
Endostar
Intervention Description
7.5mg/m2/d, continuous infusion, in parallel with radiotherapy
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
1 month after initial treatment
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
2 year
Title
Serum VEGF Levels
Time Frame
at baseline and 1 month after initial treatment
Title
VEGF levels in tumor tissue
Time Frame
at baseline and 1 month after initial treatment
Title
Incidence of Adverse Events
Time Frame
up to 1 month after last dose
Title
Cerebral Edema
Time Frame
1 month after initial treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaodong Jiang, MD
Phone
86-0518-85605120
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaodong Jiang, MD
Organizational Affiliation
The First People's Hospital of Lianyungang
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First People's Hospital of Lianyungang
City
Lianyungang
State/Province
Jiangsu
ZIP/Postal Code
222002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Jiang, MD
Phone
0518-85605120

12. IPD Sharing Statement

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Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases

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