NCT01000428

The Role of Positron Emission Tomography (PET) During Erlotinib Treatment for Non-small Cell Lung Cancer

The Role of PET During Erlotinib Treatment to See the Responsiveness of Tumor Early in Patients With Non-small Cell Lung Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 34 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Erlotinib is an inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase. Higher response rates were observed in a subset of patients with female gender, Asian ethnicity, no smoking history, mutations in EGFR tyrosine kinase, high EGFR gene copy number and adenocarcinoma histology. However, the therapeutic effect of Erlotinib is not confined to patients whose tumors harbor EGFR mutations and other predictors of efficacy of this agent. And these tests require time and sufficiently large specimens for processing, whereas many patients with advanced NSCLC are diagnosed based on cytology alone. This study was designed to evaluate FLT-PET or FDG-PET usefulness in the early assessment of treatment response and in predicting patient outcome after erlotinib monotherapy for patients with non-small cell lung cancer prospectively. Changes in tumor FLT or FDG uptake 7 days after the initiation of treatment will be compared between responders and nonresponders based on subsequent CT scans.

Detailed description

1. Primary objectives: To see whether the % change in SUVmax of a tumor with FLT-PET or FDG-PET at 7 days after initiating erlotinib treatment compared with baseline SUVmax (ΔSUVmax) would predict the tumor's responsiveness. And the responsiveness will be decided with the CT scan after 6 weeks of erlotinib treatment. 2. Secondary objectives: To compare ΔSUVmax and the degree of tumor shrinkage in longest diameter during erlotinib treatment. To see ΔSUVmax in the tumors with stable disease. To see the time to progression and overall survival according to ΔSUVmax. To compare the result of FDG-PET and FLT-PET.

Conditions

• Erlotinib
• Lung Cancer

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-05-01
• Completion: 2011-12-01
• First posted: 2009-10-23
• Last updated: 2009-10-27

Locations

1 site across 1 country: South Korea