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:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193336
First received: September 12, 2005
Last updated: May 2, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Lung Cancer
Drug: ZD1839
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Overall response rate

Secondary Outcome Measures:
  • Overall toxicity
  • Quality of life

Estimated Enrollment: 60
Study Start Date: March 2003
Study Completion Date: September 2005
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Detailed Description:

Upon determination of eligibility, patients will be receive:

  • ZD1839
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  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: NCT00193336

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

Additional Information:
Publications:
Responsible Party: SCRI Oncology Research Consortium, SCRI
ClinicalTrials.gov Identifier: NCT00193336     History of Changes
Other Study ID Numbers: SCRI LUN 71, IRUSIRES0002
Study First Received: September 12, 2005
Last Updated: May 2, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 27, 2014