A preliminary report of a Phase II study of folinic acid, 5-fluorouracil, irinotecan (FOLFIRI) plus sunitinib with toxicity, efficacy, pharmacokinetics, biomarker, imaging data in patients with colorectal cancer with liver metastases as 1st line treatment.

摘要

This investigator (KM) initiated Phase II trial (IIT) started in 2008. Inhibition of angio-genesis with bevacizumab has become standard treatment in combination with FOLFOX or FOLFIRI in patients with mCRC [1]. The rationale for this Phase II study came from a Phase I study demonstrating, that patients with mCRC can be treated very effectively and with acceptable toxicity with FOLFIRI plus sunitinib at 37.5 mg (instead of 50 mg) [2]. FOLFIRI was given in the conventional 2 weeks schedule (2qw) whereas sunitinib was given for 4 weeks with 2 weeks off.