This is an open label single arm prospective multicenter Phase II study in around 20 patients. The primary objective of this study is to evaluate whether the addition of sunitinib to FOLFIRI results in a significant reduction of tumor vessel permeability (TVP) and blood flow (BF) measured by DCE-MRI and DCE-USI, measured on liver metastases. Secondary objectives are antitumor response, time to progression (TTP), effect on pharmacokinetics of sunitinib and biomarkers (VEGF und soluble VEGF-receptor) and drug/treatment safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
sunitinib 37 mg once daily (4 weeks on/2 weeks off)
Innere Univ.-Klinik u. Poliklinik Tumorforschung
Essen, Germany
Klinik für Tumorbiologie
Freiburg im Breisgau, Germany
Medizinische Universitätsklinik der Albert-Ludwigs-Universität Freiburg
Freiburg im Breisgau, Germany
Marienhospital
Herne, Germany
reduction of tumor vessel permeability (TVP) and blood flow (BF) measured by DCE-MRI and DCE-USI, measured on liver metastases.
Time frame: 12 weeks
Antitumour response
Time frame: 9 months
Time to progression (TTP)
Time frame: 9 months
pharmacokinetics
Time frame: 12 weeks
drug treatment safety
Time frame: 9 months
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