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Sponsors and Collaborators: |
Clinical Research Center for Solid Tumor, Korea Seoul National University Hospital Korean Cancer Study Group |
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Information provided by: | Clinical Research Center for Solid Tumor, Korea |
ClinicalTrials.gov Identifier: | NCT00830245 |
To assess the efficacy and safety of erlotinib for non-small cell lung cancer patients with leptomeningeal carcinomatosis
Condition | Intervention | Phase |
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Leptomeningeal Carcinomatosis Non-Small Cell Lung Cancer |
Drug: Erlotinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 20 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | February 2013 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Erlotinib: Experimental
Erlotinib 150mg/day (if no negative conversion --> increment to 250mg/day)
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Drug: Erlotinib
Erlotinib 150mg/day
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The following laboratory test results:
A patient with serious disease as followings
Contact: Se-Hoon Lee, MD | +82-2-2072-0832 | shlee119@snu.ac.kr |
Korea, Republic of | |
Dae Seog Heo | Recruiting |
Seoul, Korea, Republic of | |
Contact: Se-Hoon Lee, MD +82-2-2072-0832 shlee119@snu.ac.kr |
Responsible Party: | Seoul National University Hospital ( Dae Seog Heo/Professor ) |
Study ID Numbers: | CRCST-L-0005 |
Study First Received: | January 24, 2009 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00830245 History of Changes |
Health Authority: | South Korea: Institutional Review Board |
EGFR mutation Erlotinib Lung cancer leptomeningeal carcinomatosis in EGFR mutation positive non-small cell lung cancer |
Thoracic Neoplasms Erlotinib Meningeal Neoplasms Central Nervous System Neoplasms Protein Kinase Inhibitors Carcinoma Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Erlotinib Thoracic Neoplasms Respiratory Tract Neoplasms Meningeal Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Nervous System Diseases Enzyme Inhibitors Central Nervous System Neoplasms Protein Kinase Inhibitors |
Pharmacologic Actions Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Nervous System Neoplasms Neoplasms, Glandular and Epithelial |