Molecular Imaging With Erlotinib and Bevacizumab

Sponsor
University of Cologne
Study ID
NCT01047059
Phase
PHASE2
Status
Completed

Conditions

  • Non-Small-Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Jan 12, 2010
Start date
Jan 31, 2010
Status verified
May 2016
Primary completion
Oct 31, 2012
Completion
May 31, 2016

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trial Intervention
    150mg Erlotinib daily, 15mg/kg b.w. Bevacizumab on d1, d22, d43 as medication FDG-PET, FLT-PET and DCE-MRI as diagnostical tools

Primary Outcome Measure

To evaluate the accuracy of imaging findings in FDG-/FLT-PET and DCE-MRI after one week of treatment for early prediction of RECIST-based non-progression and progression-free survival after 6 weeks of therapy [ Time Frame: 24 months ]

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