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Sponsors and Collaborators: |
Dana-Farber Cancer Institute AstraZeneca Massachusetts General Hospital |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00372515 |
The primary purposes of this study are to find out if using high doses of the drug Gefitinib (Iressa) as a way to treat patients with non-small cell lung cancer that has spread to the covering of the brain and/or spinal cord (meninges) results in any bad side effects; and to determine the highest dose that can be given to patients in this setting.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: Gefitinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Study of High Dose Gefitinib (Iressa) for the Treatment of Carcinomatous Meningitis in Adult Patients With Non-Small Cell Lung Cancer and Known or Suspected EGFR Mutations |
Estimated Enrollment: | 18 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bruce Johnson, MD | 617-632-4790 | bruce_johnson@dfci.harvard.edu |
Contact: Linda K. Morse, RN | lmorse2@partners.org |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Bruce Johnson, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( David Jackman, MDq ) |
Study ID Numbers: | 05-403 |
Study First Received: | September 6, 2006 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00372515 |
Health Authority: | United States: Food and Drug Administration |
epidermal growth factor EGFR lung cancer Iressa Gefitinib |
Thoracic Neoplasms Non-small cell lung cancer Meningeal Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Meningitis Carcinoma Respiratory Tract Diseases |
Central Nervous System Infections Lung Neoplasms Lung Diseases Gefitinib Carcinoma, Non-Small-Cell Lung Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Nervous System Diseases Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |