{"id":"infusional-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":"20–30","effect":"Fatigue"},{"rate":"10–20","effect":"Cholinergic syndrome (acute)"}]},"_chembl":{"chemblId":"CHEMBL3989514","moleculeType":"Small molecule","molecularWeight":"677.19"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"5-FU (fluorouracil) is a pyrimidine antimetabolite that inhibits thymidylate synthase and gets incorporated into DNA/RNA, disrupting nucleotide synthesis. Irinotecan is a topoisomerase I inhibitor that prevents DNA religation, causing double-strand breaks during replication. Leucovorin (LV) enhances 5-FU efficacy by stabilizing the 5-FU–thymidylate synthase complex. Together, these agents provide synergistic cytotoxic activity against colorectal cancer cells.","oneSentence":"This combination chemotherapy regimen inhibits DNA synthesis and topoisomerase I to kill rapidly dividing cancer cells.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:16:11.457Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic colorectal cancer (first-line)"},{"name":"Advanced colorectal cancer"}]},"trialDetails":[{"nctId":"NCT01183494","phase":"PHASE1","title":"A Genotype-guided Study of Irinotecan Administered in Combination With 5-fluorouracil/Leucovorin (FOLFIRI) and Bevacizumab in Advanced Colorectal Cancer Patients","status":"COMPLETED","sponsor":"University of Chicago","startDate":"2009-12-12","conditions":"Metastatic Colorectal Cancer","enrollment":17},{"nctId":"NCT01996306","phase":"PHASE3","title":"A Phase III Study of 2nd-line XELIRI ± Bevacizumab vs. FOLFIRI ± Bevacizumab in mCRC","status":"COMPLETED","sponsor":"Epidemiological and Clinical Research Information Network","startDate":"2013-12-02","conditions":"Colorectal Neoplasms, Neoplasm Metastasis, Intestinal Neoplasms","enrollment":650},{"nctId":"NCT03303495","phase":"PHASE3","title":"A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC","status":"UNKNOWN","sponsor":"Sun Yat-sen University","startDate":"2011-11-14","conditions":"Colorectal Neoplasms, Neoplasm Metastasis, Intestinal Neoplasms","enrollment":280},{"nctId":"NCT01163396","phase":"PHASE2","title":"First-line FOLFOXIRI In Combination With Bevacizumab For Metastatic Colorectal Cancer","status":"COMPLETED","sponsor":"Gruppo Oncologico del Nord-Ovest","startDate":"2007-07","conditions":"Colorectal Cancer Metastatic","enrollment":57},{"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":"Infusional 5-FU/LV with Irinotecan","genericName":"Infusional 5-FU/LV with Irinotecan","companyName":"Pfizer","companyId":"pfizer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination chemotherapy regimen inhibits DNA synthesis and topoisomerase I to kill rapidly dividing cancer cells. Used for Metastatic colorectal cancer (first-line), Advanced colorectal cancer.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}