Therapy Detail

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Therapy Name Fluorouracil + Irinotecan + Leucovorin
Synonyms FOLFIRI
Therapy Description

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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).

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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
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
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 Active, not recruiting USA 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
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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 21
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
NCT04205968 Phase II Fluorouracil + Irinotecan + Leucovorin Paclitaxel + Ramucirumab Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers Recruiting USA 0
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
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) Recruiting USA | DEU 1
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 | ITA | FRA | ESP | DEU | CAN | BEL | AUS 8
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
NCT04390399 Phase II Fluorouracil + Irinotecan + Leucovorin Gemcitabine + Nab-paclitaxel Aldoxorubicin + ALT-803 + Cyclophosphamide + Gemcitabine + Nab-paclitaxel + PD-L1.t-haNK cells Aldoxorubicin + ALT-803 + Cyclophosphamide + Gemcitabine + Nab-paclitaxel 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
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
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 | ITA | GBR | FRA | ESP | DEU | BEL | AUS 2
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
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
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) Active, not recruiting 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
NCT01472016 Phase I Docetaxel ABT-700 Cetuximab Erlotinib Fluorouracil + Irinotecan + Leucovorin Study of ABT-700 in Subjects With Advanced Solid Tumors Completed 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
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
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 | DEU | CAN 5
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
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
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
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
NCT01298570 Phase II Fluorouracil + Irinotecan + Leucovorin Regorafenib Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer Completed USA 1
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
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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 14
NCT05419479 Phase Ib/II Fluorouracil + Irinotecan + Leucovorin AB154 + Sotigalimab + Zimberelimab Switch Maintenance in Pancreatic Recruiting USA 0
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
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
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
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
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


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