Leptomeningeal Carcinomatosis, Non-small Cell Lung Cancer
Conditions
Keywords
EGFR mutation, Erlotinib, Lung cancer, leptomeningeal carcinomatosis in EGFR mutation positive non-small cell lung cancer
Brief summary
To assess the efficacy and safety of erlotinib for non-small cell lung cancer patients with leptomeningeal carcinomatosis
Interventions
DRUGErlotinib
Erlotinib 150mg/day
Sponsors
Seoul National University Hospital
Korean Cancer Study Group
Clinical Research Center for Solid Tumor, Korea
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>18 2. Histologically or pathologically proven non-small cell lung cancer (NSCLC) 3. Leptomeningeal carcinomatosis confirmed by CSF cytology 4. A patients with EGFR mutation (including exon 19 deletion, L858R) 5. ECOG performance status 0-3 6. Expected life time more than at least 4 weeks 7. A patients who signed the informed consent prior to the participation in the study 8. Chemotherapy-naïve patient is eligible 9. Previous EGFR TKI is allowed if this drug was not specifically used for CNS metastases
Exclusion criteria
1. A pregnant or lactating patient 2. 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.) 3. A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study 4. 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 5. A patient with active interstitial lung disease, except simple lymphangitic lung metastasis 6. A patient with history of allergic reaction to gefitinib or erlotinib 7. 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 8. 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 9. A patient who refused to sign the informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Cytology negative conversion rate | 1 month, 2 months, 3 months, 4 months |
| Toxicities | 1 month, 2 months, 3 months, 4 months |
| Prognostic factors | N-A |
| Quality of life | 1 month, 2 months, 3 months, 4 months |
Countries
South Korea
Outcome results
None listed