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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00193336
First received: September 12, 2005
Last updated: May 2, 2011
Last verified: May 2011
History of Changes

September 12, 2005
May 2, 2011
March 2003
March 2004   (final data collection date for primary outcome measure)
Overall response rate
Same as current
Complete list of historical versions of study NCT00193336 on ClinicalTrials.gov Archive Site
  • Overall toxicity
  • Quality of life
Same as current
Not Provided
Not Provided
 
Iressa in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer
Phase II Trial of Single Agent ZD1839 (Iressa) in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer

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

Upon determination of eligibility, patients will be receive:

  • ZD1839
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
Drug: ZD1839
Not Provided
Spigel DR, Hainsworth JD, Burkett ER, Burris HA, Yardley DA, Thomas M, Jones SF, Dickson NR, Scullin DC, Bradof JE, Rubinsak JR, Brierre JE, Greco FA. Single-agent gefitinib in patients with untreated advanced non-small-cell lung cancer and poor performance status: a Minnie Pearl Cancer Research Network Phase II Trial. Clin Lung Cancer. 2005 Sep;7(2):127-32.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2005
March 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00193336
SCRI LUN 71, IRUSIRES0002
Not Provided
SCRI Oncology Research Consortium, SCRI
Sarah Cannon Research Institute
AstraZeneca
Principal Investigator: John D. Hainsworth, MD Sarah Cannon Research Institute
Sarah Cannon Research Institute
May 2011

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