Status:
TERMINATED
A Study to Assess the Efficacy of Erlotinib for Leptomeningeal Carcinomatosis in EGFR Mutation Positive Non-small Cell Lung Cancer
Lead Sponsor:
Clinical Research Center for Solid Tumor, Korea
Collaborating Sponsors:
Seoul National University Hospital
Korean Cancer Study Group
Conditions:
Leptomeningeal Carcinomatosis
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To assess the efficacy and safety of erlotinib for non-small cell lung cancer patients with leptomeningeal carcinomatosis
Eligibility Criteria
Inclusion
- Age \>18
- Histologically or pathologically proven non-small cell lung cancer (NSCLC)
- Leptomeningeal carcinomatosis confirmed by CSF cytology
- A patients with EGFR mutation (including exon 19 deletion, L858R)
- ECOG performance status 0-3
- Expected life time more than at least 4 weeks
- A patients who signed the informed consent prior to the participation in the study
- Chemotherapy-naïve patient is eligible
- Previous EGFR TKI is allowed if this drug was not specifically used for CNS metastases
Exclusion
- A pregnant or lactating patient
- A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
- A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
- A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
- A patient with active interstitial lung disease, except simple lymphangitic lung metastasis
- A patient with history of allergic reaction to gefitinib or erlotinib
- The following laboratory test results:
- Number of absolute neutrophils counts (ANC) \< 1.0ⅹ109/L
- Number of platelets \< 50 ⅹ109/L
- AST, ALT \> 2.5 ⅹupper limit of normal
- Total bilirubin \> 1.5 ⅹupper limit of normal
- Serum creatinine \> 1.5 ⅹupper limit of normal
- A patient with serious disease as followings
- Uncontrolled cardiac arrhythmia
- History of myocardial infarction within 6 months prior to the initiation of study
- Neurological or psychiatric disorder including dementia or uncontrolled seizure
- A patient who refused to sign the informed consent
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00830245
Start Date
January 1 2009
End Date
July 1 2011
Last Update
July 26 2011
Active Locations (1)
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1
Dae Seog Heo
Seoul, South Korea