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The Continuation of Erlotinib Treatment in Non-small Cell Lung Cancer Patients Whose Brain Lesion is the Only Site of Progression : Pilot Study


Phase 2
18 Years
N/A
Open (Enrolling by invite only)
Both
Non-small Cell Lung Cancer

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Trial Information

The Continuation of Erlotinib Treatment in Non-small Cell Lung Cancer Patients Whose Brain Lesion is the Only Site of Progression : Pilot Study


Inclusion Criteria:



1. Histologically or cytologically proven non small cell lung cancer

2. New developed or progression of brain lesions among patients with good control of
extracranial lesions to erlotinib

3. patients who are receiving erlotinib as salvage therapy

4. At least one unidimensionally measurable lesion with a diameter > 10mm using brain
MRI

5. at least on unidimensionally measurable or evaluable lesion

6. male or female patients aged >18 years

7. ECOG performance status 0-2

8. Adequate hematologic function

9. adequate renal function

10. adequate hepatic function

Exclusion criteria

1. leptomeningeal metastases

2. acute severe infection requiring antibiotic therapy

3. significant cardiovascular disease

4. uncontrolled DM

5. severe ophthalmologic disease

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

progression free survival

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Myungju Ahn, Ph.D., M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

2009-07-078

NCT ID:

NCT01130779

Start Date:

August 2009

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-small Cell Lung Cancer
  • Erlotinib
  • brain metastasis
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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