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

Phase 1/Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

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Trial Information

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

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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS) of Groups by FDG Response at Day 56

Outcome Description:

PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response and patients without FDG-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. Mean of the percent changes in maximal standard uptake values (mSUVmax) from FDG-PET scans was used to define FDG-PET response. Based on European Organization for Research on the Treatment of Cancer (EORTC) definitions, an objective FDG-PET response was defined an mSUVmax <-25%.

Outcome 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

Safety Issue:


Principal Investigator

Bernard Fine, M.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Tarceva
  • Positron emission technology
  • PET
  • Computerized tomography
  • CT
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms