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NCT Number: NCT00193336

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

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Upon determination of eligibility, patients will be receive:

  • ZD1839

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZD1839

Drug

Primary outcomes

  1. Overall response rate

Secondary outcomes

  1. Overall toxicity

  2. Quality of life

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

Phase II Trial of Single Agent ZD1839 (Iressa) in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer

Important dates

Study start
2003
Primary completion
2004
Study completion
2005
First posted
Sep 19, 2005
Registry last updated
May 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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