Therapy Detail

Therapy Name Cetuximab + Irinotecan
Synonym
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).
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).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF wild-type KRAS wild-type NRAS wild-type colon cancer sensitive Cetuximab + Irinotecan Guideline Actionable Erbitux (cetuximab), in combination with Camptosar (irinotecan), is included in guidelines as a second-line therapy for advanced or metastatic colon cancer patients BRAF wild-type, KRAS wild-type, and NRAS wild-type (NCCN.org). detail...
AKT1 E17K KRAS wild-type BRAF wild-type colorectal cancer predicted - resistant Cetuximab + Irinotecan Case Reports/Case Series Actionable In a retrospective analysis, 100% (2/2) of colorectal carcinoma patients harboring an AKT1 E17K mutation and wild-type KRAS/BRAF demonstrated resistance to Erbitux (cetuximab) in combination with Camptosar (irinotecan) (PMID: 25714871). 25714871
BRAF wild-type KRAS wild-type NRAS wild-type colorectal cancer predicted - sensitive Cetuximab + Irinotecan Phase II Actionable In a Phase II trial, Erbitux (cetuximab) and Camptosar (irinotecan) rechallenge resulted in a response rate of 21% (6/28, 6 partial responses) and a disease control rate of 54% (15/28) in RAS and BRAF wild-type colorectal cancer patients that acquired resistance to first-line cetuximab and irinotican-based therapy, patients with wild-type RAS in ctDNA at baseline achieved longer median progression-free survival (4.0 vs 1.9 mo, HR=0.44, p=0.03) compared to those with mutant RAS (PMID: 30476968; NCT02296203). 30476968
Clinical Trial Phase Therapies Title Recruitment Status
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
NCT02292758 Phase II Bevacizumab + Cetuximab + Irinotecan Cetuximab + Irinotecan Phase II Trial of Irinotecan, Cetuximab, and Bevacizumab Compared With Irinotecan, Cetuximab, and Placebo in KRAS-Wildtype, Irinotecan-Refractory, Metastatic Colorectal Cancer Active, not recruiting
NCT03365882 Phase II Cetuximab + Irinotecan Pertuzumab + Trastuzumab S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery Recruiting
NCT01079780 Phase II Cetuximab + Irinotecan + Ramucirumab Cetuximab + Irinotecan Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab-Containing Chemotherapy Active, not recruiting
NCT02164916 Phase II Cetuximab + Irinotecan Cetuximab + Irinotecan + Vemurafenib S1406 Phase II Study of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer Active, not recruiting