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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193336
• Other study ID #: SCRI LUN 71
• Secondary ID: IRUSIRES0002
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: May 2, 2011
• Start date: March 2003
• Est. completion date: September 2005

Study information

• Verified date: May 2011
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

Upon determination of eligibility, patients will be receive:

• ZD1839

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2005
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• ZD1839

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	AstraZeneca

References & Publications (1)

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 performan — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate
Secondary	Overall toxicity
Secondary	Quality of life