Clinical trial NCT00830245: A Study to Assess the Efficacy of Erlotinib for Leptomeningeal Carcinomatosis in EGFR Mutation Positive Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Leptomeningeal Carcinomatosis
Non-small Cell Lung Cancer
Keywords: EGFR mutation
Erlotinib
Lung cancer
leptomeningeal carcinomatosis in EGFR mutation positive non-small cell lung cancer
Lead sponsor: Clinical Research Center for Solid Tumor, Korea
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: Korean Cancer Study Group
First posted: 2009-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of erlotinib for non-small cell lung cancer patients with leptomeningeal carcinomatosis


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
Secondary outcomes:
measure: Cytology negative conversion rate
timeFrame: 1 month, 2 months, 3 months, 4 months
measure: Neurologic symptom improvement
timeFrame: 1 month, 2 months, 3 months, 4 months
measure: Response rate (extra-cranial disease)
timeFrame: 2 months, 4 months
measure: Response rate (brain)
timeFrame: 2 months, 4 months
measure: Quality of life
timeFrame: 1 month, 2 months, 3 months, 4 months
measure: Toxicities
timeFrame: 1 month, 2 months, 3 months, 4 months
measure: Prognostic factors
timeFrame: N-A
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Dae Seog Heo
Study officials:
References: