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| Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00029003 |
Purpose
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 |
|---|---|---|
|
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.)
Eligibility| 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:
Contacts and Locations
Show 98 Study Locations| Study Chair: | Howard L. West, MD | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus |
More Information
| Study ID Numbers: | CDR0000069157, SWOG-S0126 |
| Study First Received: | January 4, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00029003 History of Changes |
| 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 Adenocarcinoma, Bronchiolo-Alveolar Protein Kinase Inhibitors Recurrence Carcinoma Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Non-small Cell Lung Cancer 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 Adenocarcinoma, Bronchiolo-Alveolar Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Adenocarcinoma Gefitinib Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |