UMIN ID: UMIN000001437
Registered date:20/10/2008
Phase II study of FOLFIRI plus Bevacitumab in the treatment of Japanese patients with advanced colorectal cancer.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Colorectal cancer |
| Date of first enrollment | 2008/10/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | (1) Bevaciumab 5mg/Kg i.v. 90min. (2) CPT-11 150mg/m2 i.v. 90min. and Isovorin 200mg/m2 i.v. 90min. (3) 5-FU 400mg/m2 i.v. bolus and 5-FU 2400mg/m2 civ. 46 hours |
Outcome(s)
| Primary Outcome | Progression free survival |
|---|---|
| Secondary Outcome | Time to tretment failure Overall survival Response rete Safety |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 74years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1) Contraindications of using CPT-11, Bevacitumab, 5-FU and Leucovorin (2) Having double or more cancers within 5 yeras. (3).Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant. (4) Any subject judged by the investigator to be unfit for any reason to participate in the study |
Related Information
| Primary Sponsor | Japan Clinical Cancer Research Organization |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Japan Clinical Cancer Research Organization |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Toshifusa Nakajima |
| Address | 3-10-6, Ariake, Kotoku, Tokyo Japan |
| Telephone | 03-3570-0437 |
| jaccro@jaccro.or.jp | |
| Affiliation | Japan Clinical Cancer Research Organization Chief Director |
| scientific contact | |
| Name | Mitsugu Kochi |
| Address | 30-1, Oyaguchi-kamimachi, Itabashi-ku, Tokyo Japan |
| Telephone | 03-3972-8111 |
| kochi.mitsugu@nihon-u.ac.jp | |
| Affiliation | Nihon Universuty School of Medicine Department of Digestive Surgery |