TheranosticTrials.org

Clinical Trial · NCT00453362

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

Overview

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.

Sponsor

Unknown Organization

Phase

Phase 1/2

Contacts

Bernard Fine, M.D. (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT00453362

Drug / Compound

FLT

Isotope(s):
Target(s):
  • cytosolic thymidine kinase 1
Ligand Class: Small Molecules

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Recurrent or progressive disease after receiving at least one chemotherapy regimen for advanced or metastatic NSCLC
  • Life expectancy ≥ 3 months
  • Histologically confirmed NSCLC
  • At least one detectable lesion on FDG-PET scan and/or FLT-PET scan that is measurable on CT
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • 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)
  • Ability to take oral medication
  • 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
  • Use of an acceptable means of contraception (men and women of childbearing potential) or documentation of infertility
  • Measurable disease on computed tomography (CT)

Exclusion

  • 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)
  • 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
  • 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
  • Uncontrolled diabetes
  • 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)
  • Inability to take oral medications, disease affecting gastrointestinal absorption, or prior surgical procedure affecting gastrointestinal absorption
  • 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%