ClinicalTrials.gov
ClinicalTrials.gov Menu

The Continuation of Erlotinib

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.
ClinicalTrials.gov Identifier: NCT01130779
Recruitment Status : Unknown
Verified May 2010 by Samsung Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : May 26, 2010
Last Update Posted : May 26, 2010
Sponsor:
Information provided by:
Samsung Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Erlotinib (TARCEVA®) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
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
Study Start Date : August 2009
Estimated Primary Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: tarceva
continuation of tarceva
Drug: Erlotinib (TARCEVA®)
Erlotinib 150mg/day, everyday



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

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 6 months ]
  2. response rate [ Time Frame: 6 months ]
  3. time to treatment failure [ Time Frame: 6 months ]
  4. toxicity profiles [ Time Frame: 6 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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

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 Posted: May 26, 2010    Key Record Dates
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