{"id":"modified-bolus-5-fu-lv-with-irinotecan","safety":{"commonSideEffects":[{"rate":"40-50","effect":"Neutropenia"},{"rate":"40-50","effect":"Diarrhea"},{"rate":"30-40","effect":"Nausea/vomiting"},{"rate":"30-40","effect":"Anemia"},{"rate":"20-30","effect":"Mucositis"},{"rate":"30-40","effect":"Fatigue"},{"rate":"10-20","effect":"Thrombocytopenia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"5-Fluorouracil (5-FU) is a thymidylate synthase inhibitor that disrupts DNA synthesis and repair. Irinotecan is a topoisomerase I inhibitor that prevents DNA unwinding and causes double-strand breaks during replication. Leucovorin (folinic acid) potentiates 5-FU by stabilizing its binding to thymidylate synthase, enhancing cytotoxic effects. This triplet combination targets cancer cells through complementary mechanisms of action.","oneSentence":"This combination regimen inhibits DNA synthesis through fluorouracil and topoisomerase I inhibition via irinotecan, with leucovorin enhancing fluorouracil efficacy.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:50:09.016Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic colorectal cancer"},{"name":"Advanced gastric cancer"}]},"trialDetails":[{"nctId":"NCT06501989","phase":"PHASE2","title":"Study of 5-fluorouracil (5-FU) in Patients With Metastatic Colorectal Cancer","status":"WITHDRAWN","sponsor":"Inova Health Care Services","startDate":"2025-09-19","conditions":"Metastatic Colorectal Cancer","enrollment":""},{"nctId":"NCT01640405","phase":"PHASE3","title":"Study of 5-Fluorouracil/Leucovorin/Oxaliplatin (FOLFOX) + Bevacizumab Versus 5-Fluorouracil/Leucovorin/Oxaliplatin/Irinotecan (FOLFOXIRI) + Bevacizumab as First Line Treatment of Patients With Metastatic Colorectal Cancer Not Previously Treated and With Three or More Circulating Tumoral Cells","status":"COMPLETED","sponsor":"Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)","startDate":"2012-07","conditions":"Metastatic Colorectal Cancer","enrollment":350},{"nctId":"NCT00101686","phase":"PHASE3","title":"Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2003-02","conditions":"Colorectal Neoplasms","enrollment":547}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Modified Bolus 5-FU/LV with Irinotecan","genericName":"Modified Bolus 5-FU/LV with Irinotecan","companyName":"Pfizer","companyId":"pfizer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination regimen inhibits DNA synthesis through fluorouracil and topoisomerase I inhibition via irinotecan, with leucovorin enhancing fluorouracil efficacy. Used for Metastatic colorectal cancer, Advanced gastric cancer.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}