Therapy Detail

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

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Cetuximab Erbitux IMC-C225 EGFR Antibody 61 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|5-Fluorouracil Chemotherapy - Antimetabolite 14 Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent, which interferes with DNA and RNA synthesis thereby preventing cancer cell growth and is FDA approved for colorectal, breast, stomach, and pancreatic cancer (FDA.gov).
Irinotecan Camptosar CPT-11 TOPO1 inhibitor 11 Camptosar (irinotecan) inhibits Topoisomerase-I activity, resulting in inhibition of DNA replication, and potentially leading to cell death and 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 14 Wellcovorin (leucovorin) is a metabolite of folate that enhances the efficacy of fluoruracil (PMID: 32490554).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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
BRAF G469A colorectal cancer not predictive Cetuximab + Fluorouracil + Irinotecan + Leucovorin Case Reports/Case Series Actionable In a clinical study, the combination of Erbitux (cetuximab) with FOLFIRI as a third-line therapy resulted in stable disease with a PFS of 4.4 months in a patient with metastatic colorectal cancer harboring BRAF G469A (PMID: 31515458). 31515458
BRAF F247L colorectal cancer not predictive Cetuximab + Fluorouracil + Irinotecan + Leucovorin Case Reports/Case Series Actionable In a clinical study, the combination of Erbitux (cetuximab) with FOLFIRI as a third-line therapy resulted in a complete response with regression of the thoracic nodes and progression-free survival lasting 12.6 months in a patient with metastatic colorectal cancer harboring BRAF F247L (PMID: 31515458). 31515458
BRAF D594G colorectal cancer not predictive Cetuximab + Fluorouracil + Irinotecan + Leucovorin Case Reports/Case Series Actionable In a clinical study, the combination of Erbitux (cetuximab) with FOLFIRI resulted in one partial response with progression-free survival (PFS) of 3.2 months, and two with stable disease with PFS of 3.7 and 3.6 months in patients with metastatic colorectal cancer harboring BRAF D594G who had been previously treated with two lines of therapy (PMID: 31515458). 31515458
BRAF N581S colorectal cancer not predictive Cetuximab + Fluorouracil + Irinotecan + Leucovorin Case Reports/Case Series Actionable In a clinical study, the combination of Erbitux (cetuximab) with FOLFIRI as a first-line therapy resulted in a partial response with progression-free survival lasting 16 months in a patient with metastatic colorectal cancer harboring BRAF N581S (PMID: 31515458). 31515458

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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) Completed USA | TUR | POL | NOR | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG 7
NCT05312398 Phase II Cetuximab + Fluorouracil + Irinotecan + Leucovorin Cetuximab + Irinotecan Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen Active, not recruiting ITA 0
NCT03186326 Phase II Aflibercept + Fluorouracil + Irinotecan + Leucovorin Aflibercept + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Panitumumab Cetuximab + Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Irinotecan + Leucovorin + Panitumumab Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Avelumab Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Standard Chemotherapy vs Immunotherapie in 2nd Line Treatment of MSI Colorectal Mestastatic Cancer (SAMCO) Unknown status FRA 0
NCT04776655 Phase III Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Cetuximab + Fluorouracil + Irinotecan + Leucovorin Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB (LIBImAb) Unknown status ITA 0
NCT03874026 Phase II Cetuximab + Fluorouracil + Irinotecan + Leucovorin Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients (CIFRA) Recruiting ITA 0
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 Completed FRA 0
NCT00433927 Phase III Cetuximab + Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin 5-FU, Folinic Acid and Irinotecan (FOLFIRI) Plus Cetuximab Versus FOLFIRI Plus Bevacizumab in First Line Treatment Colorectal Cancer (CRC) Unknown status DEU 0
NCT01703390 Phase II Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Cetuximab + Fluorouracil + Irinotecan + Leucovorin Biomarker Directed Treatment in Metastatic Colorectal Cancer Completed AUT 0
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) Completed 0
NCT04554836 Phase II Cetuximab + Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Irinotecan + Leucovorin MoLiMoR - A Study With FOLFIRI-based First-line Therapy With or Without Intermittent Cetuximab Active, not recruiting DEU 0
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 ITA 0
NCT01910610 Phase III Cetuximab Irinotecan + Panitumumab Panitumumab Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Capecitabine + Oxaliplatin Cetuximab + Irinotecan Cetuximab + Fluorouracil + Irinotecan + Leucovorin Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer (STRATEGIC-1) Active, not recruiting ISR | IRL | FRA 0
NCT02934529 Phase III Cetuximab + Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Capecitabine + Fluorouracil + Leucovorin Regorafenib Metastatic Colorectal Cancer (RAS-wildtype) After Response to First-line Treatment With FOLFIR Plus Cetuximab (AIO-KRK-0114) Active, not recruiting DEU 0


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