At a glance
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A Randomised Study to Assess the Efficacy of Cetuximab Rechallenge in Patients With Metastatic Colorectal Cancer (RAS Wild-type) Responding to First-line Treatment With FOLFIRI Plus Cetuximab
In Brief
A Phase 3 clinical trial evaluating Irinotecan, Folinic Acid, and 7 other interventions for Metastatic Colorectal Cancer. Completed, enrolled 673 participants across 1 site.
Detailed Summary
The FIRE-4 study aims to define a treatment concept for patients with RAS wild-type tumours, optimised with regard to overall survival. The first-line treatment will be conducted with FOLFIRI plus cetuximab, which resulted in a significantly prolonged overall survival versus bevacizumab in the FIRE-3 study. Following initial progression (PD1) it is recommended that the treatment be continued with FOLFOX plus bevacizumab, as this concept led to significantly prolonged survival in the E3200 study. Owing to the encouraging results of the Santini study , a cetuximab rechallenge in combination with irinotecan-based chemotherapy is to be performed as part of the third-line treatment in patients who showed a response defined according to RECIST 1.1 during the first-line treatment (tumour diameter \< -30%) or presented with stable tumour disease for at least 6 months (tumour diameter +20 to -30%). The concept of the ideal sequence has not yet been studied to date in a clinical trial.
Study Details
Timeline
Interventions
Irinotecan 180 mg/m² iv, 30 - 90 min., day 1, q d15
Folinic acid (racemic) 400 mg/m² iv, 120 min. day 1, q d15
5-FU 400 mg/m² bolus day 1, q d15
5-FU 2400 mg/m² iv over 46 h day 1-2, q d15
cetuximab initially 400 mg/m² as a 120 min. infusion (≤ 5mg/min); subsequently 250 mg/m² iv respectively as a 60 min. infusion (≤ 10mg/min) day 1 + 8
Bevacizumab 7.5 mg/kg BW iv over 30 to 90 minutes: day 1
Capecitabine 1250 mg/m2 2 x day p.o. day 1-14, q d15
160 mg per day (day 1-21) (repeated on day 28)
Irinotecan 125 mg/m² iv, 60 - 90 min. weekly (D1, D8, D15, D22)
Cetuximab initially 400 mg/m² as a 120 min. infusion (≤ 5mg/min); subsequently 250 mg/m² iv respectively as a 60 min. infusion (≤ 10mg/min) weekly (D1, D8, D15, D22, D29, D36)