Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC Tarceva Positron emission technology PET Computerized tomography CT
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 88
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.

After 14 days and after 56 days of treatment with Erlotinib participants underwent FDG-PET and FLT-PET scans.

Interventions: intervention 1: 2-deoxy-2-[18F]fluoro-D-glucose (FDG) intervention 2: 3'-deoxy-3'-[18F]fluorothymidine (FLT) intervention 3: erlotinib HCl
Intervention descriptions: intervention 1: FDG prepared in sterile buffered solution for intravenous injection. Dosage was based on the participant's weight not to exceed 15 mCi (millicurie). intervention 2: FLT 7 mCi dose prepared in sterile buffered solution for intravenous injection. intervention 3: Tablets taken orally 150 mg/day.

Protocol document: