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Clinical Trials/NCT00663689
NCT00663689
Unknown
Phase 2

A Phase II Study of Erlotinib in Benefitted Patients With Asymptomatic Brain Metastases Advanced Non-Small Cell Lung Cancer By Chemotherapy.

Guangdong Provincial People's Hospital0 sites45 target enrollmentMarch 2008

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.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
January 2012
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

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)

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