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:

Collaborators:

Seoul National University Hospital

Korean Cancer Study Group

Information provided by:

Clinical Research Center for Solid Tumor, Korea

ClinicalTrials.gov Identifier:

NCT00830245

First received: January 24, 2009

Last updated: July 25, 2011

Last verified: July 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	January 24, 2009
Last Updated Date	July 25, 2011
Start Date ^ICMJE	January 2009
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 26, 2009)	Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00830245 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 26, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Assess the Efficacy of Erlotinib for Leptomeningeal Carcinomatosis in EGFR Mutation Positive Non-small Cell Lung Cancer
Official Title ^ICMJE	Not Provided
Brief Summary	To assess the efficacy and safety of erlotinib for non-small cell lung cancer patients with leptomeningeal carcinomatosis
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Leptomeningeal Carcinomatosis Non-small Cell Lung Cancer
Intervention ^ICMJE	Drug: Erlotinib Erlotinib 150mg/day
Study Arm (s)	Experimental: Erlotinib Erlotinib 150mg/day (if no negative conversion --> increment to 250mg/day) Intervention: Drug: Erlotinib
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Estimated Enrollment ^ICMJE	20
Completion Date	July 2011
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age >18 Histologically or pathologically proven non-small cell lung cancer (NSCLC) Leptomeningeal carcinomatosis confirmed by CSF cytology A patients with EGFR mutation (including exon 19 deletion, L858R) ECOG performance status 0-3 Expected life time more than at least 4 weeks A patients who signed the informed consent prior to the participation in the study Chemotherapy-naïve patient is eligible Previous EGFR TKI is allowed if this drug was not specifically used for CNS metastases Exclusion Criteria: A pregnant or lactating patient 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.) A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study 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 A patient with active interstitial lung disease, except simple lymphangitic lung metastasis A patient with history of allergic reaction to gefitinib or erlotinib 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 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 A patient who refused to sign the informed consent
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT00830245
Other Study ID Numbers ^ICMJE	CRCST-L-0005
Has Data Monitoring Committee	No
Responsible Party	Dae Seog Heo/Professor, Seoul National University Hospital
Study Sponsor ^ICMJE	Clinical Research Center for Solid Tumor, Korea
Collaborators ^ICMJE	Seoul National University Hospital Korean Cancer Study Group
Investigators ^ICMJE	Not Provided
Information Provided By	Clinical Research Center for Solid Tumor, Korea
Verification Date	July 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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