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

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinical Research Center for Solid Tumor, Korea
• Collaborators: Korean Cancer Study Group; Seoul National University Hospital
• Treatments: Erlotinib Hydrochloride

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