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

Sponsor
EPS Corporation
Study ID
NCT02246049
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
May 31, 2014
Status verified
Jun 2017
Primary completion
Feb 28, 2017
Completion
Feb 28, 2017

Study Design

Enrollment
69 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FOLFOXIRI plus bevacizumab
    Induction therapy is followed by the maintenance therapy. \[Induction treatment:FOLFOXIRI plus bevacizumab\] Administered for a maximum of 12 cycles. BV: 5mg/kg (d.i.v.) L-OHP: 85 mg/sq.m (d.i.v.) CPT-11:165mg/sq.m (d.i.v.) l-LV:200mg/sq.m (d.i.v.) 5-FU:3,200mg/sq.m (c.i.v.) Administered every 2 weeks. \[Maintenance treatment:5-FU / I-LV plus bevacizumab\] BV:5mg/kg (d.i.v.) l-LV:200mg/sq.m (d.i.v.) 5-FU:3,200mg/sq.m (c.i.v.) Administered every 2 weeks.

Primary Outcome Measure

Progression-free survival (PFS) at 10 months [ Time Frame: PFS rate at 10 months from study entry ]

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