New Zealand Formulary
Menu Close Menu

Fewer cancers.
Better survival.
Equity for all.

Systemic Anti-Cancer Therapy Regimen Library

Home > CRC Metastatic - mFOLFIRI and CETUximab [Q1W] [high dose foliNIc acid]

[Superseded] CRC Metastatic - mFOLFIRI and CETUximab [Q1W] [high dose foliNIc acid]

THIS REGIMEN HAS BEEN SUPERSEDED BY CRC Metastatic - mFOLFIRI and CETUximab [Q2W] [high dose foliNIc acid]

Treatment Overview

Cycle 1 - 14 days - Loading Dose

Cycle length:
14

Cycle 2 (and all further cycles) - 14 days - Maintenance Dose

Cycle length:
14

Cycle details

Cycle 1 - 14 days - Loading Dose

Medication Dose Route Days Max Duration
ondansetron 8 mg oral administration 1
dexamethasone * 8 mg oral administration 1, 2, 3,
8
loratadine * 10 mg oral administration 1, 8
CETUximab 400 mg/m² intravenous 1 120 minutes
atropine sulfate * 600 microgram intravenous 1 2 minutes
irinotecan 180 mg/m² intravenous 1 90 minutes
foliNIc acid 400 mg/m² intravenous 1 90 minutes
fluorouracil 400 mg/m² intravenous 1 15 minutes
fluorouracil 2400 mg/m² intravenous 1 46 hours Min: 46 hours
ondansetron 8 mg oral administration 1
CETUximab 250 mg/m² intravenous 8 60 minutes
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

Cycle 2 (and all further cycles) - 14 days - Maintenance Dose

Medication Dose Route Days Max Duration
ondansetron 8 mg oral administration 1
dexamethasone * 8 mg oral administration 1, 2, 3,
8
loratadine * 10 mg oral administration 1, 8
CETUximab 250 mg/m² intravenous 1, 8 60 minutes
atropine sulfate * 600 microgram intravenous 1 2 minutes
irinotecan 180 mg/m² intravenous 1 90 minutes
foliNIc acid 400 mg/m² intravenous 1 90 minutes
fluorouracil 400 mg/m² intravenous 1 15 minutes
fluorouracil 2400 mg/m² intravenous 1 46 hours Min: 46 hours
ondansetron 8 mg oral administration 1
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

Full details

Cycle 1 - 14 days - Loading Dose

Day: 1

Medication Dose Route Max duration Details
ondansetron 8 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
dexamethasone * 8 mg oral administration
Instructions:
ONE hour prior to CETUximab with food.
loratadine * 10 mg oral administration
Instructions:
ONE hour prior to CETUximab.
CETUximab 400 mg/m² intravenous 120 minutes
Instructions:
Maximum rate of 5 mg/min for initial loading dose. Doses above 600 mg will have a longer infusion duration than 120 minutes. Most centres have a mandatory observation period of 60 minutes after first two exposures.
atropine sulfate * 600 microgram intravenous 2 minutes
Instructions:
600 microgram = 0.6 mg. Some centres may wish to give a reduced dose of 300 micrograms (= 0.3 mg) in line with institutional policy.
irinotecan 180 mg/m² intravenous 90 minutes
Instructions:
To run concurrently with foliNIc acid.
foliNIc acid 400 mg/m² intravenous 90 minutes
Instructions:
To run concurrently with irinotecan.
fluorouracil 400 mg/m² intravenous 15 minutes
fluorouracil 2400 mg/m² intravenous 46 hours Min: 46 hours
Instructions:
Continuous infusion via pump over 46 hours.
ondansetron 8 mg oral administration
Instructions:
EIGHT hours after chemotherapy OR before bed.
domperidone 10 mg Three times daily oral administration
Instructions:
When required for nausea and/or vomiting.
loperamide 2 mg oral administration
Instructions:
Take TWO capsules (=4 mg) at onset of loose bowel motions and a further ONE capsule (=2 mg) for every loose bowel motion (maximum of EIGHT capsules in 24 hours), or use as directed by oncologist or haematologist.

Day: 2

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.

Day: 3

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.

Day: 8

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONE hour prior to CETUximab with food.
loratadine * 10 mg oral administration
Instructions:
ONE hour prior to CETUximab.
CETUximab 250 mg/m² intravenous 60 minutes
Instructions:
Maximum rate of 10 mg/min for maintenance dose. Most centres have a mandatory observation period of 60 minutes after first two exposures.

Cycle 2 (and all further cycles) - 14 days - Maintenance Dose

Day: 1

Medication Dose Route Max duration Details
ondansetron 8 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
dexamethasone * 8 mg oral administration
Instructions:
ONE hour prior to CETUximab with food.
loratadine * 10 mg oral administration
Instructions:
ONE hour prior to CETUximab.
CETUximab 250 mg/m² intravenous 60 minutes
Instructions:
Maximum rate of 10 mg/min for maintenance dose.
atropine sulfate * 600 microgram intravenous 2 minutes
Instructions:
600 microgram = 0.6 mg. Some centres may wish to give a reduced dose of 300 micrograms (= 0.3 mg) in line with institutional policy.
irinotecan 180 mg/m² intravenous 90 minutes
Instructions:
To run concurrently with foliNIc acid.
foliNIc acid 400 mg/m² intravenous 90 minutes
Instructions:
To run concurrently with irinotecan.
fluorouracil 400 mg/m² intravenous 15 minutes
fluorouracil 2400 mg/m² intravenous 46 hours Min: 46 hours
Instructions:
Continuous infusion via pump over 46 hours.
ondansetron 8 mg oral administration
Instructions:
EIGHT hours after chemotherapy OR before bed.
domperidone 10 mg Three times daily oral administration
Instructions:
When required for nausea and/or vomiting.
loperamide 2 mg oral administration
Instructions:
Take TWO capsules (=4 mg) at onset of loose bowel motions and a further ONE capsule (=2 mg) for every loose bowel motion (maximum of EIGHT capsules in 24 hours), or use as directed by oncologist or haematologist.

Day: 2

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.

Day: 3

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.

Day: 8

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONE hour prior to CETUximab with food.
loratadine * 10 mg oral administration
Instructions:
ONE hour prior to CETUximab.
CETUximab 250 mg/m² intravenous 60 minutes
Instructions:
Maximum rate of 10 mg/min for maintenance dose.

Supportive Care Factors

Factor Value
Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment
Emetogenicity: Medium
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended

References

1. Nott, L., M. Khattak, T. Price, et al. Cancer Council Australia Colorectal Cancer Guidelines Working Party. [Version URL: https://wiki.cancer.org.au/australiawiki/index.php?oldid=173114, cited 2018 Apr 16]. Available from https://wiki.cancer.org.au/australia/Guidelines:Colorectal_cancer/Systemic_therapy_molecular_pathology. In: Cancer Council Australia Colorectal Cancer Guidelines Working Party. Cl

2. Van Cutsem, E., C. H. Kohne, E. Hitre, et al. 2009. "Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer." N Engl J Med 360(14):1408-1417. , PMID: 19339720

3. Van Cutsem, E., H. J. Lenz, C. H. Kohne, et al. 2015. "Fluorouracil, Leucovorin, and Irinotecan Plus Cetuximab Treatment and RAS Mutations in Colorectal Cancer." J Clin Oncol 33(7):692-700., PMID: 25605843

4. Heinemann, V., L. F. von Weikersthal, T. Decker, et al. 2014. "FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial." Lancet Oncol 15(10):1065-1075. , PMID: 25088940

5. Van Cutsem, E., C. H. Kohne, I. Lang, et al. 2011. "Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status." J Clin Oncol 29(15):2011-2019., PMID: 21502544

6. Petrelli N, Douglass HO Jr, Herrera L, et al: The modulation of fluorouracil with leucovorin in metastatic colorectal carcinoma: A prospective randomized phase III trial—Gastrointestinal Tumor Study Group. J Clin Oncol 7::1419,1989-1426,, PMID: 2674331

7. de Gramont A, Bosset JF, Milan C, et al: Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: a French intergroup study. J Clin Oncol 15::808,1997-815,, PMID: 9053508

8. Healthcare Logistics Ltd. Erbitux New Zealand Data Sheet 4 September 2018. https://www.medsafe.govt.nz/profs/Datasheet/e/Erbituxinf.pdf (Accessed 26 November 2020)

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.