Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases

Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01410370
• Other study ID #: Endu-201107
• Status: Recruiting
• Phase: Phase 2
• First received: July 20, 2011
• Last updated: April 22, 2013
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: April 2013
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: Xiaodong Jiang, MD
• Phone: 86-0518-85605120
• Is FDA regulated: No
• Health authority: China:SFDA
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
China	The First People's Hospital of Lianyungang	Lianyungang	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.	The First People's Hospital of Lianyungang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)		1 month after initial treatment	No
Secondary	Overall Survival		2 year	No
Secondary	Serum VEGF Levels		at baseline and 1 month after initial treatment	No
Secondary	VEGF levels in tumor tissue		at baseline and 1 month after initial treatment	No
Secondary	Incidence of Adverse Events		up to 1 month after last dose	Yes
Secondary	Cerebral Edema		1 month after initial treatment	No