The Continuation of Erlotinib

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01130779
First received: May 25, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted

May 25, 2010
May 25, 2010
August 2009
August 2010   (final data collection date for primary outcome measure)
progression free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • time to treatment failure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • toxicity profiles [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Continuation of Erlotinib
The Continuation of Erlotinib Treatment in Non-small Cell Lung Cancer Patients Whose Brain Lesion is the Only Site of Progression : Pilot Study

Newly developed or progressive brain metastasis during erlotinib treatment is considered progressive disease requiring change of treatment regimens despite no progression in extracranial lesions. Given that there is a dissociation in terms of response to erlotinib between brain and extracranial sites, we intend to conduct this pilot study to determine whether the continuation of erlotinib treatment can prolong the progression free interval of extracranial lesions as long as cranial lesion is controlled separately by conventional treatment modalities such as surgical resection, stereotactic radiosurgery, and whole brain radiotherapy.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer
Drug: Erlotinib (TARCEVA®)
Erlotinib 150mg/day, everyday
Experimental: tarceva
continuation of tarceva
Intervention: Drug: Erlotinib (TARCEVA®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
23
Not Provided
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01130779
2009-07-078
Not Provided
Myungju Ahn Ph.D., M.D., Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Myungju Ahn, Ph.D., M.D. Samsung Medical Center
Samsung Medical Center
May 2010

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