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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00411047 |
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with previously untreated stage IIIB or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: gefitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II, Open Label Study of Gefitinib (IRESSA) in Treatment-Naïve Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer and Somatic Activating Mutations in the Epidermal Growth Factor Receptor |
Estimated Enrollment: | 30 |
Study Start Date: | September 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically confirmed non-small cell lung cancer (NSCLC)
Must meet ≥ 1 of the following criteria:
No symptomatic or newly diagnosed CNS metastases that have not been definitively treated with radiotherapy and/or surgery
PATIENT CHARACTERISTICS:
No evidence of clinically active interstitial lung disease
PRIOR CONCURRENT THERAPY:
No prior radiotherapy to the target lesion
United States, Washington | |
Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98109-1023 |
Principal Investigator: | Renato Martins, MD, MPH | Seattle Cancer Care Alliance |
Study ID Numbers: | CDR0000523506, UWCC-6305, UWCC-04-4112-A01, ZENECA-IRUSIRES0483 |
Study First Received: | December 11, 2006 |
Last Updated: | March 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00411047 History of Changes |
Health Authority: | United States: Federal Government |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer large cell lung cancer |
Thoracic Neoplasms Adenocarcinoma, Bronchiolo-Alveolar Protein Kinase Inhibitors Carcinoma Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Mitogens Adenocarcinoma of Lung Adenocarcinoma Carcinoma, Non-Small-Cell Lung Gefitinib Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Gefitinib Neoplasms, Glandular and Epithelial |