Who is sponsoring NCT00806663?

NCT00806663 is sponsored by Central European Society for Anticancer Drug Research.

What condition does NCT00806663 study?

NCT00806663 studies Metastatic Colorectal Cancer, Liver Metastases.

What drugs are being tested in NCT00806663?

Interventions: sunitinib added to FOLFIRI.

What is the status of NCT00806663?

NCT00806663 is currently COMPLETED.

Last reviewed 2019-02-04 · How we verify

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

NCT00806663 Phase 2 COMPLETED

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.

Details

Lead sponsor	Central European Society for Anticancer Drug Research
Phase	Phase 2
Status	COMPLETED
Enrolment	22
Start date	2008-08
Completion	2011-09

Conditions

Metastatic Colorectal Cancer
Liver Metastases

Interventions

sunitinib added to FOLFIRI

Primary outcomes

reduction of tumor vessel permeability (TVP) and blood flow (BF) measured by DCE-MRI and DCE-USI, measured on liver metastases. — 12 weeks

Countries

Germany