Last reviewed · How we verify
Irinotecan plus 5-FU plus leucovorin
This combination of irinotecan (a topoisomerase I inhibitor), 5-fluorouracil (a nucleotide analog), and leucovorin (a folate cofactor) works together to inhibit DNA synthesis and repair in cancer cells.
This combination of irinotecan (a topoisomerase I inhibitor), 5-fluorouracil (a nucleotide analog), and leucovorin (a folate cofactor) works together to inhibit DNA synthesis and repair in cancer cells. Used for Metastatic colorectal cancer, Advanced gastrointestinal malignancies.
At a glance
| Generic name | Irinotecan plus 5-FU plus leucovorin |
|---|---|
| Also known as | Onivyde, liposomal irinotecan, Camptosar, Campto, Adrucil, Carac, Efudex, Efudix, folinic acid, calcium folinate |
| Sponsor | ERYtech Pharma |
| Drug class | Chemotherapy combination (topoisomerase I inhibitor + antimetabolite + folate cofactor) |
| Target | Topoisomerase I, thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Irinotecan inhibits topoisomerase I, preventing DNA unwinding and causing cell death. 5-FU is converted to active metabolites that inhibit thymidylate synthase and incorporate into DNA/RNA, disrupting nucleotide synthesis. Leucovorin enhances 5-FU efficacy by stabilizing the 5-FU–thymidylate synthase complex. This triple combination (FOLFIRI regimen) is a standard chemotherapy backbone for colorectal cancer.
Approved indications
- Metastatic colorectal cancer
- Advanced gastrointestinal malignancies
Common side effects
- Neutropenia
- Diarrhea
- Nausea/vomiting
- Anemia
- Mucositis
- Fatigue
- Cholinergic syndrome (early diarrhea)
Key clinical trials
- Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44) (PHASE2)
- Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations (PHASE3)
- Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma (PHASE2)
- Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (PHASE3)
- Oxaliplatin Combined With Irinotecan Liposome Injection II Through Hepatic Artery Infusion (HAIC) Followed by 5-FU/LV (HAIC) or Tegorgor Oral Combination Therapy for Hepatic Metastasis of Pancreatic Cancer (PHASE2)
- A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer (PHASE3)
- Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases (PHASE2, PHASE3)
- Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |