The Continuation of Erlotinib
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 25, 2010
CompletedFirst Posted
Study publicly available on registry
May 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedMay 26, 2010
May 1, 2010
1 year
May 25, 2010
May 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression free survival
6 months
Secondary Outcomes (4)
overall survival
6 months
response rate
6 months
time to treatment failure
6 months
toxicity profiles
6 months
Study Arms (1)
tarceva
EXPERIMENTALcontinuation of tarceva
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- leptomeningeal metastases
- acute severe infection requiring antibiotic therapy
- significant cardiovascular disease
- uncontrolled DM
- severe ophthalmologic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Myungju Ahn, Ph.D., M.D.
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 25, 2010
First Posted
May 26, 2010
Study Start
August 1, 2009
Primary Completion
August 1, 2010
Last Updated
May 26, 2010
Record last verified: 2010-05