Phase II Trial of Combination Therapy With Irinotecan, S-1, and Bevacizumab (IRIS/Bev) in Patients With Unresectable or Recurrent Colorectal Cancer

Phase 2 Completed 53 enrolled Taiho Pharmaceutical Co., Ltd.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether irinotecan, S-1, and bevacizumab are safe in the treatment of unresectable or recurrent colorectal cancer

Timeline

Start: 2007-10
Primary completion: 2010-03
Completion: 2010-03

Publications

Komatsu Y, Yuki S, Sogabe S, Fukushima H, Nakatsumi H, Kobayashi Y, Iwanaga I, Nakamura M, Hatanaka K, Miyagishima T, Kudo M, Munakata M, Meguro T, Tateyama M, Sakata Y. Phase II study of combined chemotherapy with irinotecan and S-1 (IRIS) plus bevacizumab in patients with inoperable recurrent or advanced colorectal cancer. Acta Oncol. 2012 Sep;51(7):867-72. doi: 10.3109/0284186X.2012.682629. Epub 2012 May 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	5 mg/kg	Intravenous
Subject	Irinotecan	Small molecule	100 mg/m2	Intravenous
Subject	S-1	Small molecule	40 mg	Oral
Subject	S-1	Small molecule	50 mg	Oral
Subject	S-1	Small molecule	60 mg	Oral

Phase II Trial of Combination Therapy With Irinotecan, S-1, and Bevacizumab (IRIS/Bev) in Patients With Unresectable or Recurrent Colorectal Cancer

Summary

Timeline

Publications

Drugs

Indications