Back to resultsIressa in the Treatment of Brain Metastases From Non Small Cell Lung Cancer
Primary Purpose
Brain Neoplasms, Non Small Cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Iressa (Gefitinib)
Sponsored by
About this trial
This is an interventional treatment trial for Brain Neoplasms focused on measuring Non symptomatic brain metastases, Iressa
Eligibility Criteria
Inclusion Criteria: Radiologically confirmed brain metastases from Non Small Cell Lung Cancer No symptoms due to brain metastases No previous radiotherapy treatment for the Brain metastases Exclusion Criteria: No prior chemotherapy No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
Disease control rate (complete response, partial response and stable disease)
Secondary Outcome Measures
Duration of response
Time to progression
Overall Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00234442
Brief Title
Iressa in the Treatment of Brain Metastases From Non Small Cell Lung Cancer
Official Title
A Phase II, Multicentre, Non-Comparative, Open-Label Study To Evaluate The Efficacy And Tolerability Of ZD1839 (Iressa™) In Asymptomatic Radio-Naive Patients With Brain Metastases From Non-Small Cell Lung Carcinoma (NSCLC) Who Have Relapsed Following Prior Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Terminated
Why Stopped
Closed due to insufficient recruitment.
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The aim of the study is to determine if Iressa is effective in the treatment of Brain metastases from NCSLC
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms, Non Small Cell Lung Cancer
Keywords
Non symptomatic brain metastases, Iressa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Iressa (Gefitinib)
Primary Outcome Measure Information:
Title
Disease control rate (complete response, partial response and stable disease)
Secondary Outcome Measure Information:
Title
Duration of response
Title
Time to progression
Title
Overall Survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Radiologically confirmed brain metastases from Non Small Cell Lung Cancer
No symptoms due to brain metastases
No previous radiotherapy treatment for the Brain metastases
Exclusion Criteria:
No prior chemotherapy
No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucio Crino, MD
Organizational Affiliation
Bologna, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Bologna
Country
Italy
Facility Name
Research Site
City
Orbassano
Country
Italy
Facility Name
Research Site
City
Parma
Country
Italy
Facility Name
Research Site
City
Rozzano
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Iressa in the Treatment of Brain Metastases From Non Small Cell Lung Cancer
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