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

Clinical Research Center for Solid Tumor, Korea

Status and phase: Terminated; Phase 2

Conditions: Leptomeningeal Carcinomatosis; Non-small Cell Lung Cancer

Treatments: Drug: Erlotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT00830245

CRCST-L-0005

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Erlotinib

Experimental group

Description:

Erlotinib 150mg/day (if no negative conversion --\> increment to 250mg/day)

Treatment:

Drug: Erlotinib