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

NCT ID: NCT00453362

Last Updated: 2017-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2010-04-23

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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

2-deoxy-2-[18F]fluoro-D-glucose (FDG)

Intervention Type: 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)

Intervention Type: OTHER

FLT 7 mCi dose prepared in sterile buffered solution for intravenous injection.

erlotinib HCl

Intervention Type: DRUG

Tablets taken orally 150 mg/day.

Interventions

2-deoxy-2-[18F]fluoro-D-glucose (FDG)

FDG prepared in sterile buffered solution for intravenous injection. Dosage was based on the participant's weight not to exceed 15 mCi (millicurie).

Intervention Type: OTHER

3'-deoxy-3'-[18F]fluorothymidine (FLT)

FLT 7 mCi dose prepared in sterile buffered solution for intravenous injection.

Intervention Type: OTHER

erlotinib HCl

Tablets taken orally 150 mg/day.

Intervention Type: DRUG

Other Intervention Names

Tarceva

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernard Fine, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

ML20773

Identifier Type: -

Identifier Source: secondary_id

OSI3926g

Identifier Type: -

Identifier Source: org_study_id