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Study 19 of 6183 for search of: | United States, Illinois |
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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00029003 |
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of non-small cell lung cancer.
PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have 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: | Phase II Trial Of Chronic Oral ZD 1839 (IRESSA) (NSC-715055) In Both Previously-Untreated And Previously-Treated Patients With Selected Stage IIIB And IV Bronchioloalveolar Carcinoma (BAC) |
Study Start Date: | December 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to prior systemic treatment for bronchoalveolar carcinoma (yes vs no). (The previously untreated stratum closed to accrual as of 2/15/2003.)
Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 90 patients (55 for the previously untreated stratum and 35 for the previously treated stratum) will be accrued for this study within 24 months. (The previously untreated stratum closed to accrual as of 2/15/2003.)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed bronchoalveolar carcinoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Howard L. West, MD | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus |
Study ID Numbers: | CDR0000069157, SWOG-S0126 |
Study First Received: | January 4, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00029003 |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer bronchoalveolar cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Adenocarcinoma, Bronchiolo-Alveolar Lung Neoplasms Lung Diseases |
Adenocarcinoma Gefitinib Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |