A Phase II Study of Erlotinib in Benefitted Patients With Asymptomatic Brain Metastases Advanced Non-Small Cell Lung Cancer By Chemotherapy.
Overview
- Phase
- Phase 2
- Intervention
- erlotinib
- Conditions
- Non-Small Cell Lung Cancer
- Sponsor
- Guangdong Provincial People's Hospital
- Enrollment
- 45
- Primary Endpoint
- Time of asymptomatic brain metastasis turn into symptomatic brain metastasis
- Last Updated
- 18 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
non-randomized open-label uncontrolled phase II trial erlotinib 150mg qd until disease progression or unacceptable toxicity
Intervention: erlotinib
Outcomes
Primary Outcomes
Time of asymptomatic brain metastasis turn into symptomatic brain metastasis
Time Frame: 3/2008~3/2011
Secondary Outcomes
- To determine objective response (CR+PR), time to progression, 6-month survival and 1-year survival,safety.(3/2008~3/2011)