NCT00453362

A Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib

Pilot Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, multicenter, international pilot study to evaluate changes that occur in 2-deoxy-2-\[18F\]fluoro-D-glucose (FDG)- and 3'-deoxy-3'-\[18F\]fluorothymidine(FLT)-PET (Positron Emission Tomography) imaging as a result of treatment with erlotinib in patients with recurrent or refractory non-small cell lung cancer (NSCLC). The study will enroll approximately 30 patients at approximately 4 sites in Australia and 2 sites in the United States.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	2-deoxy-2-[18F]fluoro-D-glucose (FDG)	FDG prepared in sterile buffered solution for intravenous injection. Dosage was based on the participant's weight not to exceed 15 mCi (millicurie).
OTHER	3'-deoxy-3'-[18F]fluorothymidine (FLT)	FLT 7 mCi dose prepared in sterile buffered solution for intravenous injection.
DRUG	erlotinib HCl	Tablets taken orally 150 mg/day.

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-04-01
• Completion: 2010-04-23
• First posted: 2007-03-28
• Last updated: 2017-03-31
• Results posted: 2011-10-03