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, 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).
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
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
NCT05546411 Phase II Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + NIS793 + Oxaliplatin A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer Terminated 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
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
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) Recruiting ITA 0
NCT01928290 Phase II Trastuzumab Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Combination Chemotherapy in Treating Patients With Advanced Stomach, Gastroesophageal, or Esophageal Cancer Completed USA 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 Active, not recruiting USA 0
NCT06625320 Phase III Fluorouracil + Leucovorin + Liposomal irinotecan Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Gemcitabine + Nab-paclitaxel RMC-6236 Phase 3 Study of RMC-6236 in Patients with Previously Treated Metastatic Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) (RASolute 302) Recruiting USA 1
NCT06483555 Phase Ib/II Erlotinib + Gemcitabine + Nab-paclitaxel Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel (PANGEA) Not yet recruiting USA 0
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
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 Recruiting 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
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 Recruiting 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 | GBR | FRA | ESP | DEU | CAN 0
NCT02581215 Phase II Ramucirumab Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Phase II Randomized Trial of FOLFIRINOX +/- Ramucirumab in Advanced Pancreatic Cancer Unknown status 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
NCT01485744 Phase I Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Sonidegib LDE225 With Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan for Untreated Advanced Pancreatic Cancer Completed 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


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