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Sponsored by: |
Guangdong Provincial People's Hospital |
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Information provided by: | Guangdong Provincial People's Hospital |
ClinicalTrials.gov Identifier: | NCT00663689 |
This is a non-randomized open-label uncontrolled phase II trial evaluating efficacy and toxicity of erlotinib in patients with asymptomatic brain metastasis advanced NSCLC who was benefitted by first line chemotherapy. Patients with stage IV NSCLC who have one or more asymptomatic brain metastasis who was benefitted by first line chemotherapy will receive oral erlotinib 150mg once daily until disease progression or unacceptable toxicity. These patients' direct DNA sequencing of tumor tissue EGFR exons 18-21 will be analyzed The response was evaluated by RECIST criteria after the patient received erlotinib 6 weeks.If the patients present with progress disease of brain metastasis after the therapy of erlotinib, the patients will receive irradiation of brain metastasis.If the response is stable disease,partial response or complete response,he will be examined by brain MRI every 12 weeks.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer Brain Metastases |
Drug: erlotinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of Erlotinib in Benefitted Patients With Asymptomatic Brain Metastases Advanced Non-Small Cell Lung Cancer By Chemotherapy. |
Estimated Enrollment: | 45 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
non-randomized open-label uncontrolled phase II trial erlotinib 150mg qd until disease progression or unacceptable toxicity
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Drug: erlotinib
erlotinib 150mg qd until disease progression or unacceptable toxicity.
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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:
Responsible Party: | Guangdong Provincial People's Hospital ( Yilong,Wu ) |
Study ID Numbers: | cslc0803 |
Study First Received: | April 17, 2008 |
Last Updated: | April 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00663689 History of Changes |
Health Authority: | United States: Institutional Review Board |
erlotinib |
Erlotinib Thoracic Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Protein Kinase Inhibitors Carcinoma Brain Neoplasms |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasm Metastasis Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Central Nervous System Neoplasms Brain Diseases Protein Kinase Inhibitors Neoplastic Processes Neoplasms by Site Pathologic Processes Respiratory Tract Diseases Lung Neoplasms Neoplasm Metastasis Nervous System Neoplasms Erlotinib |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions Carcinoma Brain Neoplasms Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |