Efficacy of Erlotinib for Brain Metastasis of Non-Small Cell Lung Cancer
- Registration Number
- NCT00663689
- Lead Sponsor
- Guangdong Provincial People's Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 erlotinib non-randomized open-label uncontrolled phase II trial erlotinib 150mg qd until disease progression or unacceptable toxicity
- Primary Outcome Measures
Name Time Method Time of asymptomatic brain metastasis turn into symptomatic brain metastasis 3/2008~3/2011
- Secondary Outcome Measures
Name Time Method To determine objective response (CR+PR), time to progression, 6-month survival and 1-year survival,safety. 3/2008~3/2011