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 53 | 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 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|Onivyde | TOPO1 inhibitor 10 | 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 |
|---|---|---|---|---|---|---|---|
| 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 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 |
| 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 |
| 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 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 |
| 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 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 | |
| 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 |
| 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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 17 |
| 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) | Unknown status | FRA | 2 |
| 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 |
| NCT03874026 | Phase II | Cetuximab + Fluorouracil + Irinotecan + Leucovorin | Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients (CIFRA) | 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) | Active, not recruiting | FRA | 0 |
| 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 | Recruiting | ITA | 0 |
| NCT01703390 | Phase II | Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Cetuximab + Fluorouracil + Irinotecan + Leucovorin | Biomarker Directed Treatment in Metastatic Colorectal Cancer | Completed | AUT | 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 |
| 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 |
| 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) | Recruiting | ITA | 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 |
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