5-FU, Folinic Acid and Irinotecan (FOLFIRI) Plus Cetuximab Versus FOLFIRI Plus Bevacizumab in First Line Treatment Colorectal Cancer (CRC)

Sponsor
PD Dr. med. Volker Heinemann
Study ID
NCT00433927
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 5-FU — DRUG
    5-FU 400 mg/m² Bolus day 1 5-FU 2400 mg/m² iv over 46 h day 1-2
  • folinic acid — DRUG
    Folinsäure (racemisch) 400 mg/m² iv, 120 min d 1
  • irinotecan — DRUG
    Irinotecan 180 mg/m² iv, 30 - 90 min day 1
  • cetuximab — DRUG
    Cetuximab initial 400mg/m² as 120 min infusion, than 250 mg/m² iv as 60 min infusion d 1 + 8
  • bevacizumab — DRUG
    Bevacizumab 5 mg/kg iv over 30 to 90 minutes d 1

Study Details

The FIRE-3 trial is a multicenter randomized phase III trial investigating 5-FU, folinic acid and irinotecan (FOLFIRI) plus cetuximab versus FOLFIRI plus bevacizumab in first line treatment of metastatic colorectal cancer. Planned accrual is 284 evaluable patients per treatment arm. The primary study endpoint is objective response rate. Secondary endpoints are median progression free survival, median overall survival, safety, and secondary resection rate.

Key Dates

Start date
Jan 31, 2007
Status verified
Mar 2014
Primary completion
Apr 30, 2014
Completion
Dec 31, 2016

Study Design

Enrollment
568 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    FOLFIRI plus Cetuximab
  • Active Comparator: Arm B
    FOLFIRI plus Bevacizumab

Primary Outcome Measure

Objective response rate [ Time Frame: approximate 6 months after randomisation ]

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