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Phase II Trial of FOLFOXIRI + Bevacizumab in Patients With Untreated Metastatic Colorectal Cancer (BeTRI)
The purpose of this study is to evaluate the efficacy and safety of fluorouracil (5-FU), levofolinate calcium (l-LV), oxaliplatin (L-OHP) and irinotecan hydrochloride hydrate (CPT-11) (FOLFOXIRI) plus bevacizumab in untreated metastatic colorectal cancer patients who harbor Uridine diphosphate (UDP)-glucuronosyl transferase 1A1 (UGT1A1) \*1/\*1, \*1/\*6 or \*1/\*28.
Details
| Lead sponsor | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 45 |
| Start date | 2015-05-21 |
| Completion | 2019-06 |
Conditions
- Metastatic Colorectal Cancer
Interventions
- Oxaliplatin (L-OHP)
- Irinotecan hydrochloride hydrate (CPT-11)
- Continuous intravenous infusion of fluorouracil (CIV 5-FU)
- Levofolinate calcium (l-LV)
- Bevacizumab (Bmab)
Primary outcomes
- Response rate (RR) by response evaluation criteria in solid tumors (RECIST v1.1) — Up to 18 months
RR will be calculated as the ratio of the number of eligible patients who experienced a confirmed Complete response(CR) or Partial response(PR) by RECIST v1.1.
Countries
Japan