The Continuation of Erlotinib

The Continuation of Erlotinib Treatment in Non-small Cell Lung Cancer Patients Whose Brain Lesion is the Only Site of Progression : Pilot Study

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 Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Erlotinib (TARCEVA®)

• Study Type: Interventional
• Enrollment (Anticipated): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tarceva; continuation of tarceva	Drug: Erlotinib (TARCEVA®); Erlotinib 150mg/day, everyday

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
progression free survival	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	6 months
response rate	6 months
time to treatment failure	6 months
toxicity profiles	6 months

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Myungju Ahn, Ph.D., M.D., Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Anticipated): August 1, 2010
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: May 25, 2010
• First Submitted That Met QC Criteria: May 25, 2010
• First Posted (Estimate): May 26, 2010

Study Record Updates

• Last Update Posted (Estimate): May 26, 2010
• Last Update Submitted That Met QC Criteria: May 25, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Erlotinib; Non-small Cell Lung Cancer; brain metastasis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride
• Other Study ID Numbers: 2009-07-078

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No