Therapy Detail

Therapy Name Cetuximab + Fluorouracil + Irinotecan + Leucovorin
Synonym Cetuximab + FOLFIRI
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Cetuximab Erbitux EGFR Antibody 27 Erbitux (cetuximab) is a monoclonal antibody directed against EGFR, which inhibits signal transduction and cell proliferation (PMID: 28695301). Erbitux (cetuximab) is FDA approved for use in head and neck squamous cell carcinoma and KRAS wild-type, EGFR positive colorectal cancer (FDA.gov).
Fluorouracil Adrucil 5-FU Chemotherapy - Antimetabolite 10 Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent, which interferes with DNA and RNA synthesis thereby preventing cancer cell growth (NCI Drug Dictionary). Fluorouracil is FDA approved for colorectal, breast, stomach, and pancreatic cancer (FDA.gov).
Irinotecan Camptosar CPT-11|Onivyde TOPO1 inhibitor 7 Camptosar (irinotecan) inhibits Topoisomerase-I activity, resulting in inhibition of DNA replication, and potentially leading to cell death (NCI Drug Dictionary). Camptosar (irinotecan) is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic or recurrent colorectal carcinoma (FDA.gov).
Leucovorin Wellcovorin Calcium folinate|Calcium citrovorum factor|folinic acid Chemotherapy - Antimetabolite 10 Wellcovorin (leucovorin) is a metabolite of folate that enhances the efficacy of fluoruracil (NCI Drug Dictionary).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
KRAS wild-type colorectal cancer predicted - sensitive Cetuximab + Fluorouracil + Irinotecan + Leucovorin Phase III Actionable In a Phase III trial, the combination of Erbitux (cetuximab) and FOLFIRI demonstrated a significant clinical benefit in OS, PFS, and objective response compared to FOLFIRI alone in colorectal cancer patients with RAS wild-type status (PMID: 25605843). 25605843
NRAS wild-type colorectal cancer predicted - sensitive Cetuximab + Fluorouracil + Irinotecan + Leucovorin Phase III Actionable In a Phase III trial, the combination of Erbitux (cetuximab) and FOLFIRI demonstrated a significant clinical benefit in OS, PFS, and objective response compared to FOLFIRI alone in colorectal cancer patients with RAS wild-type status (PMID: 25605843). 25605843
NRAS mutant colorectal cancer no benefit Cetuximab + Fluorouracil + Irinotecan + Leucovorin Phase III Actionable In a retrospective analysis of a Phase III trial, the combination of Erbitux (cetuximab) and FOLFIRI did not demonstrate an improved clinical benefit compared to FOLFIRI alone in colorectal cancer patients with RAS mutations (PMID: 25605843). 25605843
KRAS mutant colorectal cancer no benefit Cetuximab + Fluorouracil + Irinotecan + Leucovorin Phase III Actionable In a retrospective analysis of a Phase III trial, the combination of Erbitux (cetuximab) and FOLFIRI did not demonstrate an improved clinical benefit compared to FOLFIRI alone in colorectal cancer patients with RAS mutations (PMID: 25605843). 25605843
BRAF wild-type KRAS wild-type NRAS wild-type colorectal cancer predicted - sensitive Cetuximab + Fluorouracil + Irinotecan + Leucovorin Phase II Actionable In a Phase II trial (MACBETH), first-line treatment with the combination of Erbitux (cetuximab) and FOLFIRI, followed by Erbitux (cetuximab) maintenance, demonstrated activity in BRAF/KRAS/NRAS wild-type metastatic colorectal cancer patients, resulting in a median overall survival in the intent-to-treat population of 33.2 mo and response rate of 68% (40/59), however, resulted in a 10-mo PFS rate of 50.8% (30/59), which did not meet the primary endpoint of 70% (PMID: 29450468; NCT02295930). 29450468
BRAF wild-type KRAS wild-type NRAS wild-type rectum cancer sensitive Cetuximab + Fluorouracil + Irinotecan + Leucovorin Guideline Actionable Erbitux (cetuximab), in combination with FOLFIRI, is included in guidelines for advanced or metastatic rectum cancer patients with BRAF wild-type, KRAS wild-type, and NRAS wild-type (NCCN.org). detail...
BRAF wild-type KRAS wild-type NRAS wild-type colon cancer sensitive Cetuximab + Fluorouracil + Irinotecan + Leucovorin Guideline Actionable Erbitux (cetuximab), in combination with FOLFIRI, is included in guidelines for advanced or metastatic left-sided colon tumors with BRAF wild-type, KRAS wild-type, and NRAS wild-type (NCCN.org). detail...
Clinical Trial Phase Therapies Title Recruitment Status
NCT02573220 Phase I Cetuximab + Fluorouracil + Irinotecan + Leucovorin Irinotecan Hydrochloride With FOLFIRI and Cetuximab as First-Line Therapy in Treating Patients With RAS Wild-Type Colorectal Cancer Withdrawn
NCT02928224 Phase III Cetuximab + Encorafenib Binimetinib + Cetuximab + Encorafenib Cetuximab + Irinotecan Cetuximab + Fluorouracil + Irinotecan + Leucovorin Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer (BEACON CRC) Active, not recruiting
NCT02563002 Phase III Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin Cetuximab + Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Pembrolizumab Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177) Active, not recruiting
NCT01703390 Phase II Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Cetuximab + Fluorouracil + Irinotecan + Leucovorin Biomarker Directed Treatment in Metastatic Colorectal Cancer Recruiting
NCT01442935 Phase II Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Cetuximab + Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Cetuximab + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Chemotherapies Associated With Targeted Therapies on the Resection Rate of Hepatic Metastases Active, not recruiting