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Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Jiangsu Simcere Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
The First People's Hospital of Lianyungang
Information provided by:
Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01410370
First received: July 20, 2011
Last updated: April 22, 2013
Last verified: April 2013
  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
Intervention Model: Parallel Assignment
Masking: None (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

Further study details as provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: 1 month after initial treatment ]

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

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Co., Ltd.
The First People's Hospital of Lianyungang
Investigators
Principal Investigator: Xiaodong Jiang, MD The First People's Hospital of Lianyungang
  More Information

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

Keywords provided by Jiangsu Simcere Pharmaceutical 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 August 18, 2017