Efficacy of Erlotinib for Brain Metastasis of Non-Small Cell Lung Cancer

Sponsor
Guangdong Provincial People's Hospital
Study ID
NCT00663689
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib — DRUG
    erlotinib 150mg qd until disease progression or unacceptable toxicity.

Study Details

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.

Key Dates

First listed
Apr 22, 2008
Start date
Mar 31, 2008
Status verified
Apr 2008
Primary completion
Mar 31, 2011
Completion
Jan 31, 2012

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    non-randomized open-label uncontrolled phase II trial erlotinib 150mg qd until disease progression or unacceptable toxicity

Primary Outcome Measure

Time of asymptomatic brain metastasis turn into symptomatic brain metastasis [ Time Frame: 3/2008~3/2011 ]

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