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| Therapy Name | Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin |
| Synonyms | FOLFIRINOX|FOLFOXIRI |
| 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 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). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
| 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 |