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A Study to Assess the Efficacy of Erlotinib for Leptomeningeal Carcinomatosis in EGFR Mutation Positive Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by Clinical Research Center for Solid Tumor, Korea, January 2009
First Received: January 24, 2009   Last Updated: January 26, 2009   History of Changes
Sponsors and Collaborators: Clinical Research Center for Solid Tumor, Korea
Seoul National University Hospital
Korean Cancer Study Group
Information provided by: Clinical Research Center for Solid Tumor, Korea
ClinicalTrials.gov Identifier: NCT00830245
  Purpose

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


Condition Intervention Phase
Leptomeningeal Carcinomatosis
Non-Small Cell Lung Cancer
Drug: Erlotinib
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Erlotinib hydrochloride Erlotinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Clinical Research Center for Solid Tumor, Korea:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cytology negative conversion rate [ Time Frame: 1 month, 2 months, 3 months, 4 months ] [ Designated as safety issue: No ]
  • Neurologic symptom improvement [ Time Frame: 1 month, 2 months, 3 months, 4 months ] [ Designated as safety issue: No ]
  • Response rate (extra-cranial disease) [ Time Frame: 2 months, 4 months ] [ Designated as safety issue: No ]
  • Response rate (brain) [ Time Frame: 2 months, 4 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 1 month, 2 months, 3 months, 4 months ] [ Designated as safety issue: No ]
  • Toxicities [ Time Frame: 1 month, 2 months, 3 months, 4 months ] [ Designated as safety issue: Yes ]
  • Prognostic factors [ Time Frame: N-A ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Erlotinib: Experimental
Erlotinib 150mg/day (if no negative conversion --> increment to 250mg/day)
Drug: Erlotinib
Erlotinib 150mg/day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830245

Contacts
Contact: Se-Hoon Lee, MD +82-2-2072-0832 shlee119@snu.ac.kr

Locations
Korea, Republic of
Dae Seog Heo Recruiting
Seoul, Korea, Republic of
Contact: Se-Hoon Lee, MD     +82-2-2072-0832     shlee119@snu.ac.kr    
Sponsors and Collaborators
Clinical Research Center for Solid Tumor, Korea
Seoul National University Hospital
Korean Cancer Study Group
  More Information

No publications provided

Responsible Party: Seoul National University Hospital ( Dae Seog Heo/Professor )
Study ID Numbers: CRCST-L-0005
Study First Received: January 24, 2009
Last Updated: January 26, 2009
ClinicalTrials.gov Identifier: NCT00830245     History of Changes
Health Authority: South Korea: Institutional Review Board

Keywords provided by Clinical Research Center for Solid Tumor, Korea:
EGFR mutation
Erlotinib
Lung cancer
leptomeningeal carcinomatosis in EGFR mutation positive non-small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Erlotinib
Meningeal Neoplasms
Central Nervous System Neoplasms
Protein Kinase Inhibitors
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Erlotinib
Thoracic Neoplasms
Respiratory Tract Neoplasms
Meningeal Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Enzyme Inhibitors
Central Nervous System Neoplasms
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009