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

• Status: Completed
• Trial end date: 2010-04-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Collaborator: Roche Pharma AG
• Treatments: Alovudine; Dideoxynucleosides; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Signed Informed Consent Form(s)

• Histologically confirmed NSCLC

• Recurrent or progressive disease after receiving at least one chemotherapy regimen for advanced or metastatic NSCLC

• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

• Age ≥ 18 years

• Recovery from reversible acute effects of prior anti-cancer therapy (chemotherapy, radiotherapy, or investigational treatment) to NCI Common Toxicity Criteria for Adverse Events (NCI CTCAE) Grade ≤ 1 (excluding alopecia)

• Ability to comply with the study and follow-up procedures, including all specified imaging studies

• Ability to take oral medication

• Availability of archival diagnostic paraffin-embedded tumor tissue and willingness to provide sufficient tissue for testing for EGFR levels in tumor by both immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH)

• Life expectancy ≥ 3 months

• Measurable disease on computed tomography (CT)

• At least one detectable lesion on FDG-PET scan and/or FLT-PET scan that is measurable on CT

• Use of an acceptable means of contraception (men and women of childbearing potential) or documentation of infertility

Exclusion Criteria:

• Prior treatment with an investigational or marketed agent for the purpose of inhibiting epidermal growth factor receptor (EGFR) (including, but not limited to, erlotinib and gefitinib)

• Chemotherapy, radiotherapy, or investigational treatment within 14 days or within 5 half-lives of the active molecules in the chemotherapy or investigational treatment, whichever is longer, prior to study entry or from which patients have not yet recovered

• Inability to take oral medications, disease affecting gastrointestinal absorption, or prior surgical procedure affecting gastrointestinal absorption

• Uncontrolled diabetes

• Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within 1 month prior to study entry, hepatic, renal, or metabolic disease)

• Pregnancy or lactation

• History of another malignancy in the past 2 years, unless the malignancy has been adequately treated, is currently not detectable, and is associated with a 5-year survival > 90%

• Claustrophobia

• Any other disease, condition, physical examination finding, or clinical laboratory finding which, in the opinion of the investigator, makes the patient inappropriate for the study