A Study to Assess the Efficacy of Erlotinib for Leptomeningeal Carcinomatosis in EGFR Mutation Positive Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and safety of erlotinib for non-small cell lung cancer patients with leptomeningeal carcinomatosis

Conditions
-----------------
Leptomeningeal Carcinomatosis, Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Erlotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erlotinib<br>Erlotinib 150mg/day (if no negative conversion --> increment to 250mg/day) | Drug: Erlotinib<br>* Erlotinib 150mg/day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytology negative conversion rate |  | 1 month, 2 months, 3 months, 4 months | 
| Neurologic symptom improvement |  | 1 month, 2 months, 3 months, 4 months | 
| Response rate (extra-cranial disease) |  | 2 months, 4 months | 
| Response rate (brain) |  | 2 months, 4 months | 
| Quality of life |  | 1 month, 2 months, 3 months, 4 months | 
| Toxicities |  | 1 month, 2 months, 3 months, 4 months | 
| Prognostic factors |  | N-A | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EGFR mutation, Erlotinib, Lung cancer, leptomeningeal carcinomatosis in EGFR mutation positive non-small cell lung cancer