Therapy Detail

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Therapy Name Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin
Synonyms FOLFIRINOX|FOLFOXIRI
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 that interferes with DNA and RNA synthesis, thereby preventing cancer cell growth (PMID: 28520376). Adrucil (fluorouracil) is FDA-approved for use in patients with adenocarcinoma of the colon, rectum, breast, stomach, and pancreas (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).
Oxaliplatin Eloxatin Diaminocyclohexane Oxalatoplatinum Chemotherapy - Platinum 7 Eloxatin (oxaliplatin) is comprised of a platinum complex, which causes DNA-platinum cross-links, inhibition of DNA replication and transcription, and cell toxicity, and is FDA approved for colorectal cancer (FDA.gov).

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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
NCT04158349 Phase I Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Intraperitoneal Oxaliplatin in Combo w IV mFOLFIRI for Peritoneal Carcinomatosis From Colorectal & Appendiceal Cancer (IPOX-FOLFIRI) Terminated USA 0
NCT06079346 Phase II Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin + Trabedersen A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer (STOP-PC) Recruiting USA 0
NCT06483555 Phase Ib/II Erlotinib + Gemcitabine + Nab-paclitaxel Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel (PANGEA) Recruiting USA 0
NCT05077800 Phase II Elraglusib + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + Losartan + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Elraglusib + Fluorouracil + Irinotecan + Leucovorin + Losartan + Oxaliplatin FOLFIRINOX + 9-Ing-41 + Losartan In Pancreatic Cancer Active, not recruiting USA 0
NCT01821729 Phase II Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Losartan Proton w/FOLFIRINOX-Losartan for Pancreatic Cancer Unknown status USA 0
NCT04807972 Phase II ABBV-927 + Budigalimab + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin ABBV-927 + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis Terminated USA | ISR | ESP | AUS 2
NCT06069778 Phase Ib/II Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + MVT-5873 + Oxaliplatin Safety, Tolerability, and Efficacy of mFOLFIRINOX +/- BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma Terminated USA 0
NCT03970252 Phase Ib/II Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + Nivolumab + Oxaliplatin Nivolumab in Combination With Chemotherapy Before Surgery in Treating Patients With Borderline Resectable Pancreatic Cancer Completed USA 0
NCT03563248 Phase II Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + Losartan + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + Losartan + Nivolumab + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + Nivolumab + Oxaliplatin Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer Active, not recruiting USA 0
NCT04612530 Phase I Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Nivolumab IMO-2125 + Nivolumab PANFIRE-3 Trial: Assessing Safety and Efficacy of Irreversible Electroporation (IRE) + Nivolumab + CpG for Metastatic Pancreatic Cancer Unknown status NLD 0
NCT01896869 Phase II Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Ipilimumab A Phase 2, Multicenter Study of FOLFIRINOX Followed by Ipilimumab With Allogenic GM-CSF Transfected Pancreatic Tumor Vaccine in the Treatment of Metastatic Pancreatic Cancer Completed USA 0
NCT04229004 Phase III Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Gemcitabine + Nab-paclitaxel A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer Completed USA 0
NCT01928290 Phase II Trastuzumab Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Combination Chemotherapy in Treating Patients With Advanced Stomach, Gastroesophageal, or Esophageal Cancer Completed USA 0
NCT05968326 Phase II Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Atezolizumab + Autogene cevumeran + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected Pancreatic Ductal Adenocarcinoma (IMCODE003) Recruiting USA | SWE | NLD | GBR | FRA | ESP | DEU | CAN | BEL 1
NCT06333314 Phase II Dostarlimab-gxly Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Doxorubicin Gemcitabine Gemcitabine + Nab-paclitaxel Doxorubicin + Trabectedin Fluorouracil + Leucovorin + Oxaliplatin Cisplatin + Etoposide Cisplatin + Gemcitabine Cisplatin + Doxorubicin + Etoposide Capecitabine + Oxaliplatin Doxorubicin + Ifosfamide Carboplatin + Etoposide Carboplatin + Paclitaxel Docetaxel + Fluorouracil + Leucovorin + Oxaliplatin Mitotane Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI (Pan-MSI-ACSE) Recruiting FRA 0
NCT07024615 Phase I ASP2138 Gemcitabine + Nab-paclitaxel Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Capecitabine + Gemcitabine A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer Recruiting USA 0
NCT02581215 Phase II Ramucirumab Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Phase II Randomized Trial of FOLFIRINOX +/- Ramucirumab in Advanced Pancreatic Cancer Completed USA 0
NCT06625320 Phase III Fluorouracil + Leucovorin + Liposomal irinotecan Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Gemcitabine + Nab-paclitaxel Daraxonrasib Phase 3 Study of RMC-6236 in Patients with Previously Treated Metastatic Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) (RASolute 302) Active, not recruiting USA | ITA | FRA | ESP | DEU 2
NCT05546411 Phase II Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + NIS793 + Oxaliplatin A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer Terminated USA 0
NCT05062889 Phase II Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Capecitabine + Oxaliplatin Trifluridine-tipiracil hydrochloride Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab + Tucatinib Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients (ERASE-CRC) Suspended ITA 0
NCT01485744 Phase I Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Sonidegib LDE225 With Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan for Untreated Advanced Pancreatic Cancer Completed USA 0


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