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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
  Purpose
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.

Condition Intervention Phase
Non-small Cell Lung Cancer Drug: Erlotinib (TARCEVA®) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Continuation of Erlotinib Treatment in Non-small Cell Lung Cancer Patients Whose Brain Lesion is the Only Site of Progression : Pilot Study

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • progression free survival [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 23
Study Start Date: August 2009
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tarceva
continuation of tarceva
Drug: Erlotinib (TARCEVA®)
Erlotinib 150mg/day, everyday

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130779


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Myungju Ahn, Ph.D., M.D. Samsung Medical Center
  More Information

Responsible Party: Myungju Ahn Ph.D., M.D., Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01130779     History of Changes
Other Study ID Numbers: 2009-07-078
First Submitted: May 25, 2010
First Posted: May 26, 2010
Last Update Posted: May 26, 2010
Last Verified: May 2010

Keywords provided by Samsung Medical Center:
Non-small Cell Lung Cancer
Erlotinib
brain metastasis

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action