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

This study has been terminated.
(Closed due to insufficient recruitment.)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00234442
First received: October 5, 2005
Last updated: June 29, 2009
Last verified: June 2009
  Purpose

The aim of the study is to determine if Iressa is effective in the treatment of Brain metastases from NCSLC


Condition Intervention Phase
Brain Neoplasms
Non Small Cell Lung Cancer
Drug: Iressa (Gefitinib)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Disease control rate (complete response, partial response and stable disease)

Secondary Outcome Measures:
  • Duration of response
  • Time to progression
  • Overall Survival

Estimated Enrollment: 47
Study Start Date: July 2004
Estimated Study Completion Date: February 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234442

Locations
Italy
Research Site
Bologna, Italy
Research Site
Orbassano, Italy
Research Site
Parma, Italy
Research Site
Rozzano, Italy
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Lucio Crino, MD Bologna, Italy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00234442     History of Changes
Other Study ID Numbers: 1839IL/0569
Study First Received: October 5, 2005
Last Updated: June 29, 2009
Health Authority: Italy: Ministry of Health

Keywords provided by AstraZeneca:
Non symptomatic brain metastases
Iressa

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014