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Therapy Name | Fluorouracil + Irinotecan + Leucovorin |
Synonyms | FOLFIRI |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Fluorouracil | Adrucil | 5-FU|5-Fluorouracil | 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 | TOPO1 inhibitor 11 | 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). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT03806309 | Phase II | OSE 2101 Nivolumab + OSE 2101 Fluorouracil + Irinotecan + Leucovorin | Maintenance Therapy With OSE2101 Vaccine Alone or in Combination With Nivolumab, or FOLFIRI After Induction Therapy With FOLFIRINOX in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (TEDOPAM) | Recruiting | FRA | 0 |
NCT02213289 | Phase Ib/II | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Docetaxel + Fluorouracil Trastuzumab Fluorouracil + Irinotecan + Leucovorin Rilotumumab | PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression | Completed | USA | 0 |
NCT02508077 | Phase II | Fluorouracil + Irinotecan + Leucovorin Panitumumab | FOLFIRI and Panitumumab in Treating Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer | Terminated | USA | 0 |
NCT01937715 | Phase II | Bevacizumab Gedatolisib Fluorouracil + Irinotecan + Leucovorin | A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer | Terminated | USA | ESP | CAN | 0 |
NCT04008030 | Phase III | Nivolumab Fluorouracil + Irinotecan + Leucovorin Cetuximab Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab Ipilimumab + Nivolumab | A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) (CheckMate 8HW) | Recruiting | USA | TUR | ROU | NOR | NLD | ITA | IRL | GRC | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG | 4 |
NCT01472016 | Phase I | Docetaxel ABT-700 Cetuximab Erlotinib Fluorouracil + Irinotecan + Leucovorin | Study of ABT-700 in Subjects With Advanced Solid Tumors | Completed | 0 | |
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 | |
NCT05419479 | Phase Ib/II | Fluorouracil + Irinotecan + Leucovorin AB154 + Sotigalimab + Zimberelimab | Switch Maintenance in Pancreatic | Recruiting | USA | 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 |
NCT04825288 | Phase Ib/II | Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Irinotecan + Leucovorin + XB2001 | XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer (1-BETTER) | Completed | USA | 0 |
NCT04793958 | Phase III | Adagrasib + Cetuximab Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin | Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10) | Active, not recruiting | USA | ROU | POL | NLD | ITA | IRL | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG | 11 |
NCT02305758 | Phase II | Fluorouracil + Irinotecan + Leucovorin Bevacizumab Veliparib | Study Comparing Veliparib Plus FOLFIRI Versus Placebo Plus FOLFIRI With or Without Bevacizumab in Previously Untreated Metastatic Colorectal Cancer | Completed | 0 | |
NCT01298570 | Phase II | Fluorouracil + Irinotecan + Leucovorin Regorafenib | Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer | Completed | USA | IRL | 0 |
NCT04390399 | Phase II | Fluorouracil + Irinotecan + Leucovorin Gemcitabine + Nab-paclitaxel Aldoxorubicin + Cyclophosphamide + Gemcitabine + Nab-paclitaxel + Nogapendekin alfa inbakicept + PD-L1.t-haNK cells Aldoxorubicin + Cyclophosphamide + Gemcitabine + Nab-paclitaxel + Nogapendekin alfa inbakicept | Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer | Active, not recruiting | USA | 0 |
NCT01653470 | Phase I | Carboplatin Fluorouracil + Irinotecan + Leucovorin BMS-906024 Paclitaxel | Study to Evaluate Safety & Tolerability of BMS-906024 in Combination With Chemotherapy & to Define DLTs & MTD of BMS-906024 in Combination With One of the Following Chemotherapy Regimens; Weekly Paclitaxel, 5FU+Irinotecan or Carboplatin+Paclitaxel in Subjects With Advanced / Metastatic Solid Tumors | Completed | USA | CAN | BEL | 0 |
NCT05480306 | Phase II | Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin DKN-01 + Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Irinotecan + Leucovorin | Phase 2 Study of DKN-01 in Colorectal Cancer (DeFianCe) | Active, not recruiting | USA | DEU | 1 |
NCT02482441 | Phase I | Rosmantuzumab Fluorouracil + Irinotecan + Leucovorin | A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10 | Completed | USA | 0 |
NCT01652482 | Phase II | Cetuximab Duligotuzumab Fluorouracil + Irinotecan + Leucovorin | A Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI in Second Line in Patients With KRAS Wild-Type Metastatic Colorectal Cancer | Completed | USA | ROU | NZL | ITA | GBR | FRA | ESP | DEU | BEL | AUS | 0 |
NCT03803553 | Phase III | Binimetinib + Cetuximab + Encorafenib Nivolumab Fluorouracil + Irinotecan + Leucovorin | Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer | Recruiting | USA | 0 |
NCT02890355 | Phase II | Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Irinotecan + Leucovorin + Veliparib | FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients With Metastatic Pancreatic Cancer | Active, not recruiting | USA | 0 |
NCT02605044 | Phase III | Masitinib Fluorouracil + Irinotecan + Leucovorin | Study to Compare the Efficacy and Safety of Masitinib in Combination With FOLFIRI to Placebo in Combination With FOLFIRI in Second Line Treatment of Patients With Metastatic Colorectal Cancer | Terminated | GBR | FRA | 1 |
NCT02046538 | Phase II | Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Aflibercept | Phase II Study of Zaltrap and Chemotherapy for Advanced Resectable Colorectal Cancer | Withdrawn | USA | 0 |
NCT01312857 | Phase II | Panitumumab Fluorouracil + Irinotecan + Leucovorin Floxuridine | Study of Hepatic Arterial Infusion With Intravenous Irinotecan, 5FU and Leucovorin With or Without Panitumumab, in Patients With Wild Type RAS Who Have Resected Hepatic Metastases From Colorectal Cancer | Completed | USA | 0 |
NCT01814501 | Phase II | Fluorouracil + Irinotecan + Leucovorin Panitumumab | Panitumumab and Chemotherapy in Patients With Advanced Colorectal Cancer After Prior Therapy With Bevacizumab | Unknown status | USA | 0 |
NCT06252649 | Phase III | Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Irinotecan + Leucovorin + Panitumumab + Sotorasib | Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naive Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301) | Recruiting | USA | TUR | BRA | AUS | ARG | 5 |
NCT05062317 | Phase II | Capecitabine Leucovorin Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin | Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases | Recruiting | USA | 0 |
NCT06490536 | Phase III | Fluorouracil + Leucovorin + Oxaliplatin Ipilimumab + Nivolumab Irinotecan + Temozolomide Fluorouracil + Leucovorin Capecitabine Fluorouracil + Irinotecan + Leucovorin Fluorouracil Capecitabine + Oxaliplatin | The Sagittarius Trial | Recruiting | ITA | ESP | 0 |
NCT04348045 | Phase II | Durvalumab + Selumetinib Fluorouracil + Irinotecan + Leucovorin Olaparib | Personalized Maintenance Therapy for m-PDAC Using Olaparib or Selumetinib + Durvalumab, Based on BRCAness and KRAS Status. (MAZEPPA) | Active, not recruiting | FRA | 0 |
NCT01260415 | Phase II | Panitumumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Fluorouracil + Irinotecan + Leucovorin | A Study of Perioperative Chemotherapy Plus Panitumumab in Patients With Colorectal Cancer Liver Metastases | Completed | CAN | 0 |
NCT01274624 | Phase I | Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Pelareorep | Study of REOLYSIN; in Combination With FOLFIRI and Bevacizumab in FOLFIRI Naive Patients With KRAS Mutant Metastatic Colorectal Cancer | Completed | USA | 0 |
NCT01488552 | Phase Ib/II | Oxaliplatin Fluorouracil + Irinotecan + Leucovorin Gemcitabine + Nab-paclitaxel Metformin | Gemcitabine+Nab-paclitaxel and FOLFIRINOX and Molecular Profiling for Patients With Advanced Pancreatic Cancer | Completed | USA | 0 |
NCT04205968 | Phase II | Fluorouracil + Irinotecan + Leucovorin Paclitaxel + Ramucirumab | Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers | Recruiting | USA | 0 |
NCT03665441 | Phase III | Eryaspase + Gemcitabine + Nab-paclitaxel Eryaspase + Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Irinotecan + Leucovorin Gemcitabine + Nab-paclitaxel | Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC (Trybeca-1) | Completed | USA | GBR | FRA | 0 |
NCT02753127 | Phase III | Fluorouracil + Irinotecan + Leucovorin Napabucasin | A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CanStem303C) | Completed | USA | NLD | ITA | ISR | FRA | ESP | DEU | CZE | CAN | BEL | AUS | 5 |
NCT01803282 | Phase I | Andecaliximab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Carboplatin + Pemetrexed Disodium Fluorouracil + Irinotecan + Leucovorin Gemcitabine + Nab-paclitaxel Carboplatin + Paclitaxel Paclitaxel Bevacizumab | Safety and Tolerability Study in Solid Tumors | Completed | USA | 0 |
NCT03336216 | Phase II | Cabiralizumab + Gemcitabine + Nab-paclitaxel + Nivolumab Cabiralizumab + Nivolumab Fluorouracil + Irinotecan + Leucovorin Gemcitabine + Nab-paclitaxel Cabiralizumab + Fluorouracil + Irinotecan + Leucovorin + Nivolumab | A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer | Completed | USA | ITA | GBR | ESP | DNK | DEU | CHE | CAN | 3 |
NCT02024607 | Phase Ib/II | Capecitabine + Oxaliplatin Bevacizumab + Napabucasin Napabucasin + Regorafenib Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Napabucasin Fluorouracil + Irinotecan + Leucovorin | A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer | Completed | USA | CAN | 0 |