Spots Global Cancer Trial Database for FOLFIRI and Sunitinib in Metastatic Colorectal Cancer
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Trial Identification
Brief Title: FOLFIRI and Sunitinib in Metastatic Colorectal Cancer
Official Title: A Prospective Angiogenic Imaging Study With DCE-MRI and DCE-USI in Patients With Colorectal Cancer and Liver Metastases Receiving Sunitinib in Addition to 5-FU, Folinic Acid and Irinotecan (FOLFIRI) as 1st Line Therapy
Study ID: NCT00806663
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Innere Univ.-Klinik u. Poliklinik Tumorforschung, Essen, , Germany
Klinik für Tumorbiologie, Freiburg, , Germany
Medizinische Universitätsklinik der Albert-Ludwigs-Universität Freiburg, Freiburg, , Germany
Marienhospital, Herne, , Germany
Contact Details
Name: Klaus Mross, MD
Affiliation: Klinik für Tumorbiologie
Role: STUDY_CHAIR
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