Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases

Simcere

Status and phase: Unknown; Phase 2

Conditions: Brain Metastases

Treatments: Drug: Endostar; Radiation: 6MV-X ray

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01410370

Endu-201107

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

treatment

Experimental group

Description:

Radiotherapy plus Endostar

Treatment:

Radiation: 6MV-X ray

Drug: Endostar

control

Active Comparator group

Description:

Radiotherapy

Treatment:

Radiation: 6MV-X ray