We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Continuation of Erlotinib

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Samsung Medical Center.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01130779
First Posted: May 26, 2010
Last Update Posted: May 26, 2010
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.
Information provided by:
Samsung Medical Center
May 25, 2010
May 26, 2010
May 26, 2010
August 2009
August 2010   (Final data collection date for primary outcome measure)
progression free survival [ Time Frame: 6 months ]
Same as current
No Changes Posted
  • overall survival [ Time Frame: 6 months ]
  • response rate [ Time Frame: 6 months ]
  • time to treatment failure [ Time Frame: 6 months ]
  • toxicity profiles [ Time Frame: 6 months ]
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Unknown status
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
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
 
 
NCT01130779
2009-07-078
Not Provided
Not Provided
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