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

Phase 2

Terminated

• Conditions: Leptomeningeal Carcinomatosis; Non-small Cell Lung Cancer
• Interventions: Drug: Erlotinib

• Registration Number: NCT00830245
• Lead Sponsor: Clinical Research Center for Solid Tumor, Korea

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-24
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Status Verified: 2011-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2011-07-25
• Last Update Posted: 2011-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overall survival	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dae Seog Heo; 🇰🇷 Seoul, Korea, Republic of