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

Sponsor

SCRI Development Innovations, LLC (Other)

Overall Status

Completed

CT.gov ID

NCT00193336

Collaborator

AstraZeneca (Industry)

Enrollment

30.1

Duration (Months)

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Mar 1, 2003

Actual Primary Completion Date :

Mar 1, 2004

Actual Study Completion Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

Overall response rate []

Secondary Outcome Measures

Overall toxicity []
Quality of life []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.