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

June 29, 2009 updated by: AstraZeneca

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy
        • Research Site
      • Orbassano, Italy
        • Research Site
      • Parma, Italy
        • Research Site
      • Rozzano, Italy
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Disease control rate (complete response, partial response and stable disease)

Secondary Outcome Measures

Outcome Measure
Time to progression
Duration of response
Overall Survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Lucio Crino, MD, Bologna, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion

February 1, 2006

Study Registration Dates

First Submitted

October 5, 2005

First Submitted That Met QC Criteria

October 5, 2005

First Posted (Estimate)

October 7, 2005

Study Record Updates

Last Update Posted (Estimate)

June 30, 2009

Last Update Submitted That Met QC Criteria

June 29, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1839IL/0569

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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