NCT01047059

Molecular Imaging With Erlotinib and Bevacizumab

Clinical Pilot to Evaluate the Accuracy of FDG-/FLT-PET and DCE-MRI for Early Prediction of Non-Progression in Patients With Advanced Non Squamous Cell Non Small Cell Lung Cancer (NSCLC) Treated With Erlotinib and Bevacizumab and to Associate Imaging Findings With Molecular Markers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The patients will be treated with erlotinib and bevacizumab for a six-week period. Imaging procedures will be performed at baseline, after one week of therapy and after the six weeks of treatment. The combination of erlotinib and bevacizumab represents an effective therapeutic strategy in NSCLC with the highest response rates ever reported for relapsed NSCLC having been observed recently in a phase II trial. Early differentiation of patients profiting and of patients not profiting from this therapy is of major relevance for further improving this targeted therapy approach and to develop more effective, personalized treatment strategies. We aim at this early identification by the combination of molecular and functional imaging tools (FDG-, FLT-PET, DCE-MRI), molecular marker analyses in tissue and peripheral blood (EGFR- and KRAS mutational status and high throughput mutational profiling in tumor tissue, angiogenesis-associated biomarkers and expression profiling in peripheral blood) and pharmokokinetic analyses. From the combined analyses of these tools we expect a better understanding of the host-drug interaction as a precondition for further improvement of erlotinib-bevacizumab combination therapy in NSCLC

Conditions

• Non-Small-Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Erlotinib, Bevacizumab	Erlotinib 150mg/d d1-d43 p.o. Bevacizumab 15mg/kg b. w. d1, d22, d43 i.v.
DRUG	Fluoro-D-glucose	Tracer for PET imaging
DRUG	Fluoro-L-thymidine	FLT-PET tracer for imaging
DRUG	Gadolinium-DPTA	Contrast agent for DCE-MRI imaging

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-10-01
• Completion: 2016-05-01
• First posted: 2010-01-12
• Last updated: 2016-05-20

Locations

1 site across 1 country: Germany