Phase 2 Completed N=88 Treatment

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

Source: ClinicalTrials.gov NCT00453362 ↗

Enrolled (actual)

Serious AEs

43.5%

Results posted

Oct 2011

Primary outcomePrimary: Progression Free Survival (PFS) of Groups by FDG Response at Day 56 — 28.1; 12.1 weeks — p=0.017

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression Free Survival (PFS) of Groups by FDG Response at Day 56	28.1; 12.1	0.017 sig
PRIMARY 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	32.1; 14.9	0.076
PRIMARY Progression Free Survival of Groups by FLT Response at Day 56	39.9; 13.1	0.008 sig
PRIMARY Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56	NA; 12.9	0.049 sig
PRIMARY Overall Survival of Groups by FDG Response at Day 56	NA; 7.8	0.073
PRIMARY Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56	12.2; 8.8	0.618
PRIMARY Overall Survival of Groups by FLT Response at Day 56	NA; 8.4	0.163
PRIMARY Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56	NA; 8	0.327
SECONDARY Percentage of Patients With FDG-PET Responses	7.7; 11.5	—
SECONDARY Percentage of Patients With FLT-PET Responses	7.7; 7.7	—
SECONDARY FDG Response in Subgroups by CT Response at Day 56	75; 0	—
SECONDARY FLT Response in Subgroups by CT Response at Day 56	50; 0	—
SECONDARY Number of Participants With Adverse Events Due to FLT-PET Imaging	—	—

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

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Data sourced from ClinicalTrials.gov (NCT00453362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.