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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 has been terminated.
(low accrual rate)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00830245
First Posted: January 27, 2009
Last Update Posted: July 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Seoul National University Hospital
Korean Cancer Study Group
Information provided by:
Clinical Research Center for Solid Tumor, Korea
January 24, 2009
January 27, 2009
July 26, 2011
January 2009
July 2011   (Final data collection date for primary outcome measure)
Overall survival [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00830245 on ClinicalTrials.gov Archive Site
  • Cytology negative conversion rate [ Time Frame: 1 month, 2 months, 3 months, 4 months ]
  • Neurologic symptom improvement [ Time Frame: 1 month, 2 months, 3 months, 4 months ]
  • Response rate (extra-cranial disease) [ Time Frame: 2 months, 4 months ]
  • Response rate (brain) [ Time Frame: 2 months, 4 months ]
  • Quality of life [ Time Frame: 1 month, 2 months, 3 months, 4 months ]
  • Toxicities [ Time Frame: 1 month, 2 months, 3 months, 4 months ]
  • Prognostic factors [ Time Frame: N-A ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Efficacy of Erlotinib for Leptomeningeal Carcinomatosis in EGFR Mutation Positive Non-small Cell Lung Cancer
Not Provided
To assess the efficacy and safety of erlotinib for non-small cell lung cancer patients with leptomeningeal carcinomatosis
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Leptomeningeal Carcinomatosis
  • Non-small Cell Lung Cancer
Drug: Erlotinib
Erlotinib 150mg/day
Experimental: Erlotinib
Erlotinib 150mg/day (if no negative conversion --> increment to 250mg/day)
Intervention: Drug: Erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
July 2011
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00830245
CRCST-L-0005
No
Not Provided
Not Provided
Dae Seog Heo/Professor, Seoul National University Hospital
Clinical Research Center for Solid Tumor, Korea
  • Seoul National University Hospital
  • Korean Cancer Study Group
Not Provided
Clinical Research Center for Solid Tumor, Korea
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP