Overview

This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatments erlotinib, fdg-/flt-pet
Phase phase 2
Target EGFR
Sponsor Lung Cancer Group Cologne
Start date October 2007
End date December 2009
Trial size 40 participants
Trial identifier NCT00568841, 06159, 2005-005393-73

Summary

This is a Phase-II Study to evaluate the accuracy of Fluorodeoxyglucose-/Fluorothymidine-Positron Emission Tomography (FDG-/FLT-PET) analyses for early prediction of non-progression in patients with non-small-cell lung cancer (NSCLC) treated with Erlotinib.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
erlotinib
erlotinib p.o. (by mouth), 150 mg once daily for week 1-6 (day 1-42)
fdg-/flt-pet

Primary Outcomes

Measure
To evaluate the accuracy of FDG-/FLT-PET analyses for early prediction of non-progression in patients with NSCLC treated with Erlotinib
time frame: 34 months

Secondary Outcomes

Measure
To identify PET characteristics for progression, response and stable disease; To identify EGFR and KRAS sequence characteristics for clinical response and stable disease; Safety; Response rates; One-year FFTF; One-year OS; Median overall survival time
time frame: 34 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Written informed consent - ≥ 18 years of age - Untreated non-small-cell lung cancer stage IIIB/IV - Life expectancy > 3 months - Performance status ECOG 0-2 Exclusion Criteria: - Concurrent systemic immune therapy, chemotherapy or therapy with any anticancer drug not indicated in the study protocol - Any investigational agent(s) within 4 weeks prior to study entry - Previous administration of any EGFR-targeted therapy (antibodies, small molecules and others) - Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information

Additional Information

Official title A Phase-II Clinical Trial to Evaluate the Accuracy of FDG-/FLT-PET for Early Prediction of Non-progression in Patients With Advanced NSCLC Treated With Erlotinib and to Associate PET Findings With Molecular Markers
Principal investigator Juergen Wolf, Prof., Dr.
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Lung Cancer Group Cologne.