Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases

NCT01410370 | Unknown Phase 2

• 1 other identifier: Endu-201107
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Metastases

Keywords

Endostar; Radiotherapy; Brain Metastases

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  1 month after initial treatment

Secondary Outcomes (5)

• Overall Survival

  2 year

• Serum VEGF Levels

  at baseline and 1 month after initial treatment

• VEGF levels in tumor tissue

  at baseline and 1 month after initial treatment

• Incidence of Adverse Events

  up to 1 month after last dose

• Cerebral Edema

  1 month after initial treatment

Study Arms (2)

treatment

EXPERIMENTAL

Radiotherapy plus Endostar

Radiation: 6MV-X ray; Drug: Endostar

control

ACTIVE COMPARATOR

Radiotherapy

Radiation: 6MV-X ray

Interventions

6MV-X ray RADIATION

3Gy/time, 5 times/week, a total of 10 times

control; treatment

Endostar DRUG

7.5mg/m2/d, continuous infusion, in parallel with radiotherapy

treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead
• The First People's Hospital of Lianyungang: collaborator

Study Sites (1)

The First People's Hospital of Lianyungang

Lianyungang, Jiangsu, 222002, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

endostar protein

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Xiaodong Jiang, MD

  The First People's Hospital of Lianyungang

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaodong Jiang, MD

CONTACT

86-0518-85605120

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: August 5, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 24, 2013

Record last verified: 2013-04

Locations

CN (1)