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
  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 2

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

Resource links provided by NLM:


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
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830245

Locations
Korea, Republic of
Dae Seog Heo
Seoul, Korea, Republic of
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: Dae Seog Heo/Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00830245     History of Changes
Other Study ID Numbers: CRCST-L-0005
Study First Received: January 24, 2009
Last Updated: July 25, 2011
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

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

ClinicalTrials.gov processed this record on August 25, 2014