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Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases

This study is currently recruiting participants.
Verified April 2013 by Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
Sponsor:
Collaborator:
The First People's Hospital of Lianyungang
Information provided by:
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01410370
First received: July 20, 2011
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Brain Metastases
 Radiation: 6MV-X ray
Drug: Endostar
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy for the Treatment of Patients With Brain Metastases

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Jiangsu Simcere Pharmaceutical R&D Co. Ltd.:

Primary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: 1 month after initial treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • Serum VEGF Levels [ Time Frame: at baseline and 1 month after initial treatment ] [ Designated as safety issue: No ]
  • VEGF levels in tumor tissue [ Time Frame: at baseline and 1 month after initial treatment ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events [ Time Frame: up to 1 month after last dose ] [ Designated as safety issue: Yes ]
  • Cerebral Edema [ Time Frame: 1 month after initial treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410370

Contacts
Contact: Xiaodong Jiang, MD 86-0518-85605120

Locations
China, Jiangsu
The First People's Hospital of Lianyungang Recruiting
Lianyungang, Jiangsu, China, 222002
Contact: Xiaodong Jiang, MD     0518-85605120        
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
The First People's Hospital of Lianyungang
Investigators
Principal Investigator: Xiaodong Jiang, MD The First People's Hospital of Lianyungang
  More Information

No publications provided

Responsible Party: Xiaodong Jiang, The First People's Hospital of Lianyungang
ClinicalTrials.gov Identifier: NCT01410370     History of Changes
Other Study ID Numbers: Endu-201107
Study First Received: July 20, 2011
Last Updated: April 22, 2013
Health Authority: China:SFDA

Keywords provided by Jiangsu Simcere Pharmaceutical R&D Co. Ltd.:
Endostar
Radiotherapy
Brain Metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
 Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013