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

Sponsor
Genentech, Inc.
Study ID
NCT00453362
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 28, 2007
Start date
Dec 31, 2006
Status verified
Oct 2011
Primary completion
Apr 30, 2010
Completion
Apr 23, 2010

Study Design

Enrollment
88 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib
    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.

Primary Outcome Measure

Progression Free Survival (PFS) of Groups by FDG Response at Day 56 [ Time Frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years ]

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