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
Official title: Pilot Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC
Tarceva
Positron emission technology
PET
Computerized tomography
CT
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Roche Pharma AG
First posted: 2007-03-28
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression Free Survival (PFS) of Groups by FDG Response at Day 56
timeFrame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
measure: PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56
timeFrame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
measure: Progression Free Survival of Groups by FLT Response at Day 56
timeFrame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
measure: Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56
timeFrame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
measure: Overall Survival of Groups by FDG Response at Day 56
timeFrame: From first erlotinib treatment to death, assessed up to 2 years
measure: Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56
timeFrame: From first erlotinib treatment to death, assessed up to 2 years
measure: Overall Survival of Groups by FLT Response at Day 56
timeFrame: From first erlotinib treatment to death, assessed up to 2 years
measure: Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56
timeFrame: From first erlotinib treatment to death, assessed up to 2 years
Secondary outcomes:
measure: Percentage of Patients With FDG-PET Responses
timeFrame: Day 14 and Day 56
measure: Percentage of Patients With FLT-PET Responses
timeFrame: Day 14 and Day 56
measure: FDG Response in Subgroups by CT Response at Day 56
timeFrame: Day 56
measure: FLT Response in Subgroups by CT Response at Day 56
timeFrame: Day 56
measure: Number of Participants With Adverse Events Due to FLT-PET Imaging
timeFrame: From screening to Day 112 assessment visit or study discontinuation or termination, whichever is first. On visits after Day 112, only SAE were recorded.
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Bernard Fine, M.D.
role: STUDY_DIRECTOR
References: