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 |
|---|---|---|---|---|---|---|---|
| PALB2 mutant | pancreatic adenocarcinoma | sensitive | Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin | Guideline | Actionable | FOLFIRINOX is included in guidelines as a preferred first-line therapy for patients with locally advanced or metastatic pancreatic adenocarcinoma harboring PALB2 mutations with good performance status (ECOG 0 -1) (NCCN.org). | detail... |
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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 |
| 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 | 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 | Recruiting | NLD | 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 |
| 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 | Active, not recruiting | USA | ESP | AUS | 3 |
| 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 |
| 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) | Recruiting | ITA | 0 |
| NCT02581215 | Phase II | Ramucirumab Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin | Phase II Randomized Trial of FOLFIRINOX +/- Ramucirumab in Advanced 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 |
| 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 |
| 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 |
| 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 | 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 |
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