Iressa in the Treatment of Brain Metastases From Non Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234442
Recruitment Status : Terminated (Closed due to insufficient recruitment.)
First Posted : October 7, 2005
Last Update Posted : June 30, 2009
Information provided by:

October 5, 2005
October 7, 2005
June 30, 2009
July 2004
Not Provided
Disease control rate (complete response, partial response and stable disease)
Same as current
Complete list of historical versions of study NCT00234442 on Archive Site
  • Duration of response
  • Time to progression
  • Overall Survival
Same as current
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Iressa in the Treatment of Brain Metastases From Non Small Cell Lung Cancer
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
The aim of the study is to determine if Iressa is effective in the treatment of Brain metastases from NCSLC
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Brain Neoplasms
  • Non Small Cell Lung Cancer
Drug: Iressa (Gefitinib)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
February 2006
Not Provided

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Principal Investigator: Lucio Crino, MD Bologna, Italy
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP