NCT02246049

A Multicenter, Clinical Study of FOLFOXIRI With Bevacizumab As First-line Therapy in Patients With mCRC

A Multicenter, Clinical Phase II Study of FOLFOXIRI With Bevacizumab As First-line Therapy in Patients With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: EPS Corporation · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study to assess efficacy and tolerability of combination therapy FOLFOXIRI with Bevacizumab (BV) as a first-line therapy in patients with metastatic colorectal cancer.

Detailed description

This is a single-arm, multicentre phase II study evaluating the efficacy and safety of Bevacizumab (BV) in combination with oxaliplatin, irinotecan hydrochloride, fluorouracil, and leucovorin calcium regimen ( FOLFOXIRI +BV ; Falcone et al. ASCO2013) as first-line treatment for Japanese metastatic colorectal cancer patients. This study is composed two steps because of collecting safety issue in Japanese patient. As First step (Step 1), It assess on the initial safety information in ten Japanese patients of the end of 2nd cycle. it is evaluated by DMC. In parallel with the confirmation of the initial safety issue, register up to 65 cases in total and Step 1 patient, to evaluate the efficacy and safety (Step2).

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	Given IV
DRUG	5-fluorouracil	Given IV
DRUG	Irinotecan hydrochloride	Given IV
DRUG	Leucovorin calcium	Given IV
DRUG	Oxaliplatin	Given IV

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2014-09-22
• Last updated: 2017-06-19

Locations

1 site across 1 country: Japan