The Continuation of Erlotinib

Samsung Medical Center23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small Cell Lung Cancer

Interventions

Erlotinib (TARCEVA®)DRUG

Erlotinib 150mg/day, everyday

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

progression free survival

Time frame: 6 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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