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

Non-small Cell Lung Cancer Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00830245
• Other study ID #: CRCST-L-0005
• Status: Terminated
• Phase: Phase 2
• First received: January 24, 2009
• Last updated: July 25, 2011
• Start date: January 2009
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: Clinical Research Center for Solid Tumor, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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) < 1.0?109/L

• Number of platelets < 50 ?109/L

• AST, ALT > 2.5 ?upper limit of normal

• Total bilirubin > 1.5 ?upper limit of normal

• Serum creatinine > 1.5 ?upper 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Leptomeningeal Carcinomatosis
• Lung Neoplasms
• Meningeal Carcinomatosis
• Non-small Cell Lung Cancer

Intervention

Drug:
• Erlotinib
Erlotinib 150mg/day

Locations

Country	Name	City	State
Korea, Republic of	Dae Seog Heo	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Clinical Research Center for Solid Tumor, Korea	Korean Cancer Study Group, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		1 year	No
Secondary	Cytology negative conversion rate		1 month, 2 months, 3 months, 4 months	No
Secondary	Neurologic symptom improvement		1 month, 2 months, 3 months, 4 months	No
Secondary	Response rate (extra-cranial disease)		2 months, 4 months	No
Secondary	Response rate (brain)		2 months, 4 months	No
Secondary	Quality of life		1 month, 2 months, 3 months, 4 months	No
Secondary	Toxicities		1 month, 2 months, 3 months, 4 months	Yes
Secondary	Prognostic factors		N-A	No