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A Phase I Study of ZD1839 and Palliative Thoracic Radiotherapy in Patients With 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.
ClinicalTrials.gov Identifier: NCT00255489
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : January 25, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to characterize the safety profile of ZD1839 in combination with Palliative thoracic Radiotherapy in patients with non-small cell lung cancer

Condition or disease Intervention/treatment Phase
Non-small-cell Lung Cancer Drug: Gefitinib Procedure: palliative thoracic radiotherapy Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of ZD1839 (Iressa) and Palliative Thoracic Radiotherapy in Patients With Non-small Cell Lung Cancer
Study Start Date : May 2004
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. To characterize the safety profile of ZD 1839 in these patients

Secondary Outcome Measures :
  1. To measure the quality of life compared to baseline
  2. To measure the change in disease related symptoms compared to baseline

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of written informed consent
  • Patients requiring low dose palliative thoracic irradiation to a field size of less than or equal to 150cm2
  • Histologically or cytologically conformed non-small cell lung cancer
  • Aged 18 or over

Exclusion Criteria:

  • Previous thoracic radiotherapy
  • Any condition that may pre-dispose the patient to suffer an individual drug-relaged DLT (dose limiting toxicity) event
  • Known hypersensitivity to any component of study medication
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255489


Locations
United Kingdom
Research Site
Edinburgh, United Kingdom
Research Site
Leeds, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Iressa Medical Sciences Director, MD AstraZeneca
More Information

ClinicalTrials.gov Identifier: NCT00255489     History of Changes
Other Study ID Numbers: 1839IL/0524
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: January 25, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action