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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 25, 2010
Last Updated: May 25, 2010
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 16, 2014