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Iressa in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00193336
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : May 3, 2011
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
SCRI Development Innovations, LLC

Brief Summary:
Because of the demonstrated single agent activity and excellent tolerability in patients with refractory non-small cell lung cancer, ZD1839 may be of benefit in the first-line treatment of patients with advanced non-small cell lung cancer who have poor performance status. In this phase II trial, we will investigate the single agent activity of first-line ZD1839 in patients with advanced non-small cell lung cancer with poor performance status

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: ZD1839 Phase 2

Detailed Description:

Upon determination of eligibility, patients will be receive:

  • ZD1839

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Single Agent ZD1839 (Iressa) in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer
Study Start Date : March 2003
Actual Primary Completion Date : March 2004
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib




Primary Outcome Measures :
  1. Overall response rate

Secondary Outcome Measures :
  1. Overall toxicity
  2. Quality of life


Information from the National Library of Medicine

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

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

  • Biopsy proven non-small cell lung cancer
  • Recurrent non-small cell lung cancer after previous surgery or radiation
  • Advanced disease (stage IIIb or IV)
  • No previous chemotherapy or biological therapy
  • Require significant assistance with activities of daily living
  • Measurable disease
  • Adequate bone marrow, liver and kidney function
  • Give written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Brain metastasis
  • Meningeal metastasis
  • Other uncontrolled malignancies
  • Women pregnant or lactating
  • No measurable disease outside previous radiation therapy field

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.


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): NCT00193336


Sponsors and Collaborators
SCRI Development Innovations, LLC
AstraZeneca
Investigators
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC

Additional Information:
Publications of Results:
Responsible Party: SCRI Oncology Research Consortium, SCRI
ClinicalTrials.gov Identifier: NCT00193336     History of Changes
Other Study ID Numbers: SCRI LUN 71
IRUSIRES0002
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: May 3, 2011
Last Verified: May 2011

Keywords provided by SCRI Development Innovations, LLC:
NSCLC Lung Cancer
Non Small Cell Lung Cancer

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