MedTrace Logo

Metastatic Colorectal Cancer (RAS-wildtype) After Response to First-line Treatment With FOLFIR Plus Cetuximab

NCT02934529 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 673

Last updated 2025-04-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Irinotecan

Irinotecan 180 mg/m² iv, 30 - 90 min., day 1, q d15

DRUG

Folinic Acid

Folinic acid (racemic) 400 mg/m² iv, 120 min. day 1, q d15

DRUG

5-FU

5-FU 400 mg/m² bolus day 1, q d15

DRUG

5-FU

5-FU 2400 mg/m² iv over 46 h day 1-2, q d15

DRUG

Cetuximab

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

DRUG

Bevacizumab

Bevacizumab 7.5 mg/kg BW iv over 30 to 90 minutes: day 1

DRUG

Capecitabine

Capecitabine 1250 mg/m2 2 x day p.o. day 1-14, q d15

DRUG

regorafenib

160 mg per day (day 1-21) (repeated on day 28)

DRUG

Irinotecan 125mg

Irinotecan 125 mg/m² iv, 60 - 90 min. weekly (D1, D8, D15, D22)

DRUG

Cetuximab wkly

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)

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Volker Heinemann, Prof. Dr. · Maximilians University of Munich, Comprehensive Cancer Center and Medical Dept. III

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2025-01-30
Completion
2025-01-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02934529 on ClinicalTrials.gov