NCT00806663

FOLFIRI and Sunitinib in Metastatic Colorectal Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Central European Society for Anticancer Drug Research · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Colorectal Cancer
• Liver Metastases

Interventions

Type	Name	Description
DRUG	sunitinib added to FOLFIRI	sunitinib 37 mg once daily (4 weeks on/2 weeks off)

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-07-01
• Completion: 2011-09-01
• First posted: 2008-12-11
• Last updated: 2019-02-06

Locations

4 sites across 1 country: Germany