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

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

Study Overview

• Status: Terminated
• Conditions: Non-small Cell Lung Cancer; Leptomeningeal Carcinomatosis
• Intervention / Treatment: Drug: Erlotinib

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Dae Seog Heo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erlotinib; Erlotinib 150mg/day (if no negative conversion --> increment to 250mg/day)	Drug: Erlotinib; Erlotinib 150mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: January 24, 2009
• First Submitted That Met QC Criteria: January 26, 2009
• First Posted (Estimate): January 27, 2009

Study Record Updates

• Last Update Posted (Estimate): July 26, 2011
• Last Update Submitted That Met QC Criteria: July 25, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Lung cancer; Erlotinib; EGFR mutation; leptomeningeal carcinomatosis in EGFR mutation positive non-small cell lung cancer
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Meningeal Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma; Meningeal Carcinomatosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride
• Other Study ID Numbers: CRCST-L-0005