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Molecular Imaging With Erlotinib and Bevacizumab

NCT01047059 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-05-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Cologne

    lead OTHER

Principal Investigators

  • Jürgen Wolf, MD, Prof. · Lung Cancer Group Cologne (LCGC)

  • Matthias Scheffler, MD · Lung Cancer Group Cologne (LCGC)

  • Lucia Nogova, MD · Lung Cancer Group Cologne (LCGC)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-10-31
Completion
2016-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01047059 on ClinicalTrials.gov