Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC

Phase 3 Completed 330 enrolled Hellenic Oncology Research Group University Hospital of Crete · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with the addition of Avastin as 1st line treatment of colorectal cancer.

Timeline

Start: 2006-12
Primary completion: 2010-02
Completion: 2010-02

Publications

Souglakos J, Ziras N, Kakolyris S, Boukovinas I, Kentepozidis N, Makrantonakis P, Xynogalos S, Christophyllakis Ch, Kouroussis Ch, Vamvakas L, Georgoulias V, Polyzos A. Randomised phase-II trial of CAPIRI (capecitabine, irinotecan) plus bevacizumab vs FOLFIRI (folinic acid, 5-fluorouracil, irinotecan) plus bevacizumab as first-line treatment of patients with unresectable/metastatic colorectal cancer (mCRC). Br J Cancer. 2012 Jan 31;106(3):453-9. doi: 10.1038/bjc.2011.594. Epub 2012 Jan 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	5 mg/kg	Intravenous
Subject	Bevacizumab	Monoclonal antibody	7.5 mg/kg	Intravenous
Subject	Capecitabine	Small molecule	2000 mg/m2	Oral
Subject	Irinotecan	Small molecule	150 mg/m2	Intravenous
Subject	Irinotecan	Small molecule	250 mg/m2	Intravenous
Subject	Leucovorin	Small molecule	200 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	400 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	600 mg/m2	Intravenous

Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC

Summary

Timeline

Publications

Drugs

Indications