A phase II study on the efficacy and safety of topotecan in the treatment of patients with brain metastases - ND

• Conditions: Brain metastases; MedDRA version: 6.1Level: PTClassification code 10061287

• Registration Number: EUCTR2006-004084-66-IT
• Lead Sponsor: OSPEDALE ONCOLOGICO DI BARI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Unresectable brain metastases

2. Patients with chemosensitive neoplasms must have received chemoterapic for advanced desease

3. Asymptomatic brain metastases

4. Age>18 and <75 years

5. Life expectancy of 12 weeks at least

6. Normal kidney and liver parameters
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Histologically proved brain glioma

2. Contemporary radiotherapy

3. Immunotherapy

4. Pregnancy or breast-feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the clinical efficacy in terms of objective response and time of response;Secondary Objective: To assess the time to progression and toxicity and safety to the therapy;Primary end point(s): Assessment of the efficacy of topotecan in patients with brain metastases