The Continuation of Erlotinib

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01130779
• Other study ID #: 2009-07-078
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: May 25, 2010
• Last updated: May 25, 2010
• Start date: August 2009

Study information

• Verified date: May 2010
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 23
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Erlotinib (TARCEVA®)
Erlotinib 150mg/day, everyday

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		6 months	No
Secondary	overall survival		6 months	No
Secondary	response rate		6 months	No
Secondary	time to treatment failure		6 months	No
Secondary	toxicity profiles		6 months	Yes