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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

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


Upon determination of eligibility, patients will be receive:

- ZD1839


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI LUN 71

NCT ID:

NCT00193336

Start Date:

March 2003

Completion Date:

September 2005

Related Keywords:

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

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