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The Continuation of Erlotinib

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Erlotinib (TARCEVA®)
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small Cell Lung Cancer, Erlotinib, brain metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tarceva

Arm Description

continuation of tarceva

Outcomes

Primary Outcome Measures

progression free survival

Secondary Outcome Measures

overall survival
response rate
time to treatment failure
toxicity profiles

Full Information

First Posted
May 25, 2010
Last Updated
May 25, 2010
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01130779
Brief Title
The Continuation of Erlotinib
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 Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Non-small Cell Lung Cancer, Erlotinib, brain metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tarceva
Arm Type
Experimental
Arm Description
continuation of tarceva
Intervention Type
Drug
Intervention Name(s)
Erlotinib (TARCEVA®)
Intervention Description
Erlotinib 150mg/day, everyday
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
6 months
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
6 months
Title
response rate
Time Frame
6 months
Title
time to treatment failure
Time Frame
6 months
Title
toxicity profiles
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically proven non small cell lung cancer New developed or progression of brain lesions among patients with good control of extracranial lesions to erlotinib patients who are receiving erlotinib as salvage therapy At least one unidimensionally measurable lesion with a diameter > 10mm using brain MRI at least on unidimensionally measurable or evaluable lesion male or female patients aged >18 years ECOG performance status 0-2 Adequate hematologic function adequate renal function adequate hepatic function Exclusion criteria leptomeningeal metastases acute severe infection requiring antibiotic therapy significant cardiovascular disease uncontrolled DM severe ophthalmologic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myungju Ahn, Ph.D., M.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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The Continuation of Erlotinib

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