Therapy Detail
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| Therapy Name | Fluorouracil + Leucovorin + Oxaliplatin |
| Synonyms | FOLFOX |
| 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). |
| 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 |
|---|---|---|---|---|---|---|---|
| ATM W1058* ATM S1993fs | gastroesophageal adenocarcinoma | predicted - sensitive | Fluorouracil + Leucovorin + Oxaliplatin | Case Reports/Case Series | Actionable | In a retrospective analysis, treatment with the combination of Adrucil (fluorouracil), Wellcovorin (leucovorin), and Eloxatin (oxaliplatin) resulted in a partial response and a progression-free survival of 7.2 months in a patient with gastroesophageal adenocarcinoma harboring ATM W1058* and S1993fs (PMID: 37129948). | 37129948 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03844750 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin Pembrolizumab | Pembrolizumab After Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and Who Are Undergoing Liver Surgery | Recruiting | USA | 0 |
| NCT03530267 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin Aflibercept + Fluorouracil + Leucovorin | Aflibercept and 5-FU vs. FOLFOX as 1st Line Treatment for Elderly or Frail Elderly Patients With Met. Colorectal Cancer (ELDERLY) | Completed | DEU | 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 | |
| NCT03647969 | Phase II | Docetaxel + Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Ipilimumab + Leucovorin + Nivolumab + Oxaliplatin | Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Gastric Cancer | Active, not recruiting | DEU | 0 |
| NCT02923921 | Phase III | Fluorouracil + Leucovorin + Oxaliplatin + Pegilodecakin Fluorouracil + Leucovorin + Oxaliplatin | Study of AM0010 With FOLFOX Compared to FOLFOX Alone Second-line Tx in Pts With Metastatic Pancreatic Cancer | Completed | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 3 |
| NCT03504397 | Phase III | Fluorouracil + Leucovorin + Oxaliplatin + Zolbetuximab Fluorouracil + Leucovorin + Oxaliplatin | A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer (Spotlight) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 11 |
| NCT05052801 | Phase III | Bemarituzumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin | Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (FORTITUDE-101) | Recruiting | USA | ITA | FRA | ESP | CAN | BEL | AUS | 30 |
| NCT05253651 | Phase III | Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab + Tucatinib Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin | A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03) | Recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 14 |
| NCT05713838 | Phase II | Durvalumab + Fluorouracil + Leucovorin + Oxaliplatin Docetaxel + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Durvalumab | Organ Preservation With Durvalumab-based Immunotherapy in Combination With Chemoradiation as Definitive Therapy for Early Stage Esophageal Adenocarcinoma With Indication for Radical Surgery | Recruiting | DEU | 0 |
| NCT04919226 | Phase III | Fluorouracil + Leucovorin + Oxaliplatin 177Lu-edotreotide Everolimus Capecitabine + Temozolomide | Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (COMPOSE) | Recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | AUS | 2 |
| NCT05564403 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin Binimetinib + Fluorouracil + Leucovorin + Oxaliplatin | Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial) | 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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 20 |
| NCT03329248 | Phase Ib/II | Fluorouracil + Leucovorin + Oxaliplatin Avelumab + Bevacizumab + ETBX-011 + GI-4000 + Nogapendekin alfa inbakicept Capecitabine + Cyclophosphamide + Nab-paclitaxel | QUILT-3.060: Combination Immunotherapy With High-affinity Natural Killer (haNK) in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy. | Unknown status | USA | 0 |
| NCT05870800 | Phase II | Atezolizumab + Capecitabine + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Capecitabine + Oxaliplatin | Neoadjuvant Chemoimmunotherapy for Resectable Non-Metastatic Proficient Mismatch Repair (PMMR) Colon Cancer | Not yet recruiting | USA | 0 |
| NCT03281369 | Phase Ib/II | Atezolizumab + Cobimetinib Atezolizumab + Cisplatin + Fluorouracil + Tiragolumab Atezolizumab + Cisplatin + Fluorouracil Atezolizumab + Cobimetinib + Fluorouracil + Leucovorin + Oxaliplatin Atezolizumab + Fluorouracil + Leucovorin + Oxaliplatin Atezolizumab + Linagliptin Atezolizumab + PEGPH20 Atezolizumab + BKT140 Paclitaxel + Ramucirumab Cisplatin + Fluorouracil Fluorouracil + Leucovorin + Oxaliplatin Atezolizumab + Tiragolumab | A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer) | Active, not recruiting | USA | GBR | ESP | AUS | 3 |
| NCT03694522 | Phase II | Bemarituzumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin | A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT) | Completed | USA | ITA | GBR | FRA | ESP | DEU | BEL | AUS | 10 |
| NCT05564377 | Phase II | Selumetinib Binimetinib + Fulvestrant Binimetinib + Palbociclib Nilotinib + Paclitaxel Binimetinib + Fluorouracil + Leucovorin + Oxaliplatin Panitumumab + Sotorasib Binimetinib Fulvestrant Olaparib Olaparib + Selumetinib Alpelisib + Olaparib Neratinib Neratinib + Palbociclib Fluorouracil + Leucovorin + Oxaliplatin Ipatasertib + Paclitaxel | Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial | Recruiting | USA | 1 |
| NCT01792934 | Capecitabine + Oxaliplatin Bevacizumab + Capecitabine + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin | Chemotherapy and Maximal Tumor Debulking of Multi-organ Colorectal Cancer Metastases (ORCHESTRA) | Recruiting | NLD | GBR | 0 | |
| NCT02912559 | Phase III | Atezolizumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin | Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair | Active, not recruiting | USA | DEU | 1 |
| NCT02934464 | Phase III | Paclitaxel + Ramucirumab Fluorouracil + Leucovorin + Oxaliplatin Capecitabine + Oxaliplatin | Assessment of Ramucirumab Plus Paclitaxel as Switch MANteInance Versus Continuation of First-line Chemotherapy in Patients With Advanced HER-2 Negative Gastric or Gastroesophageal Junction Cancers (ARMANI) | Unknown status | ITA | 0 |
| NCT04145193 | Phase II | Durvalumab + Fluorouracil + Leucovorin + Oleclumab + Oxaliplatin Durvalumab + Fluorouracil + Leucovorin + Oxaliplatin Durvalumab + Fluorouracil + Leucovorin + Monalizumab + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin | Novel Oncology Therapies in Combination With Adjuvant Chemo in High-risk MSS-CRC | Withdrawn | 0 | |
| NCT03611556 | Phase Ib/II | Gemcitabine + Nab-paclitaxel + Oleclumab Durvalumab + Gemcitabine + Nab-paclitaxel + Oleclumab Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oleclumab + Oxaliplatin Durvalumab + Fluorouracil + Leucovorin + Oleclumab + Oxaliplatin | MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study | Completed | USA | ESP | AUS | 1 |
| NCT05476796 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin Nivolumab + Oxaliplatin + Trifluridine-tipiracil hydrochloride Oxaliplatin + Trifluridine-tipiracil hydrochloride Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin | Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer (LOGICAN) | Recruiting | FRA | 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 |
| NCT03777813 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin Durvalumab + Fluorouracil + Leucovorin + Oxaliplatin | Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer (ARION) | Recruiting | FRA | 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 |
| NCT04210115 | Phase III | Cisplatin + Fluorouracil + Pembrolizumab Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Cisplatin + Fluorouracil | Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975) | Active, not recruiting | USA | ITA | GBR | FRA | DEU | CAN | BEL | 20 |
| 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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 13 |
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