Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases

April 22, 2013 updated by: Jiangsu Simcere Pharmaceutical Co., Ltd.

Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy for the Treatment of Patients With Brain Metastases

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaodong Jiang, MD
  • Phone Number: 86-0518-85605120

Study Locations

  • China
    • Jiangsu
      • Lianyungang, Jiangsu, China, 222002
        • Recruiting
        • The First People's Hospital of Lianyungang
        • Contact:
          • Xiaodong Jiang, MD
          • Phone Number: 0518-85605120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment
Radiotherapy plus Endostar
Radiation: 6MV-X ray
3Gy/time, 5 times/week, a total of 10 times
Drug: Endostar
7.5mg/m2/d, continuous infusion, in parallel with radiotherapy
Active Comparator: control
Radiotherapy
Radiation: 6MV-X ray
3Gy/time, 5 times/week, a total of 10 times

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR)
Time Frame: 1 month after initial treatment
1 month after initial treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 2 year
2 year
Serum VEGF Levels
Time Frame: at baseline and 1 month after initial treatment
at baseline and 1 month after initial treatment
VEGF levels in tumor tissue
Time Frame: at baseline and 1 month after initial treatment
at baseline and 1 month after initial treatment
Incidence of Adverse Events
Time Frame: up to 1 month after last dose
up to 1 month after last dose
Cerebral Edema
Time Frame: 1 month after initial treatment
1 month after initial treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Collaborators

The First People's Hospital of Lianyungang

Investigators

  • Principal Investigator: Xiaodong Jiang, MD, The First People's Hospital of Lianyungang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

July 20, 2011

First Submitted That Met QC Criteria

August 4, 2011

First Posted (Estimate)

August 5, 2011

Study Record Updates

Last Update Posted (Estimate)

April 24, 2013

Last Update Submitted That Met QC Criteria

April 22, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Endu-201107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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