The Continuation of Erlotinib

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Erlotinib (TARCEVA®)

• Registration Number: NCT01130779
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Status Verified: 2010-05
• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-05-25
• Last Update Submitted: 2010-05-25
• Study First Posted: 2010-05-26
• Last Update Posted: 2010-05-26
• Primary Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 23

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tarceva	Erlotinib (TARCEVA®)	continuation of tarceva

Primary Outcome Measures

Name	Time	Method
progression free survival	6 months

Secondary Outcome Measures

Name	Time	Method
overall survival	6 months
response rate	6 months
time to treatment failure	6 months
toxicity profiles	6 months

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of