Iressa in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer
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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 |
- Overall response rate
- 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) |
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 |
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 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 Sarah Cannon Research Institute:
|
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 May 23, 2013