Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
5-Fluorouracil · 7 trials · 9 indications
PFS is defined as the time from the start of treatment to the date of disease progression or death from any cause.
DFS is calculated from the date of randomization until the first date of recurrence local, regional or distant, second primary tumor or death.
Disease-Free Survival (DFS)- are defined as local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first.
CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the induction treatment and prior to the radiation treatment. CR defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.
| Arm | Type | Description |
|---|---|---|
| 5-FU & LV | ACTIVE_COMPARATOR | * Day 1: LV 400 mg/m2 (given as a 2-hour infusion) * Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours. * This chemotherapy regimen will be administered each two weeks. |
| XELOX or modified FOLFOX-6 | EXPERIMENTAL | XELOX: * Day 1: Oxaliplatin 130 mg/m2 (2 hours infusion) * This chemotherapy regimen will be administered each two weeks. OR modified FOLFOX-6: * Day 1: Oxaliplatin 85 mg/m2 (given as a 2-hour infusion) * Day 1: LV 400 mg/m2 (given as a 2-hour infusion simultaneous to oxaliplatin) * Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours (Day 1 and 2) * This chemotherapy regimen will be administered each two weeks. |
| Docetaxel Cisplatin 5-Fluorouracil (DCF) | EXPERIMENTAL | 4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment): * Docetaxel 60mg/m² on day 1 * Cisplatin 75mg/m² on day 1 * 5-FU 750mg/m²/day on day 1 to day 5 |
| Cisplatin 5-Fluorouracil (CF) | EXPERIMENTAL | 4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment): * Cisplatin 75mg/m² on day 1 * 5-FU 750mg/m²/day on day 1 to day 5 |
| 1 | EXPERIMENTAL | Administration of docetaxel 60 mg/m² on Day 1, Cisplatin 60 mg/m² after the end of the docetaxel infusion and 5-fluorouracil (5-FU) 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5. |
| 2 | ACTIVE_COMPARATOR | Cisplatin 75 mg/m² on Day 1, 5-FU 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5. |
| Arm A: FAC | ACTIVE_COMPARATOR | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv |
| Arm B: TAC | EXPERIMENTAL | TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv |
| TAC (Docetaxel) | EXPERIMENTAL | docetaxel (75 mg/m\^2) in combination with doxorubicin (50 mg/m\^2) and cyclophosphamide (500 mg/m\^2) on day 1 every 3 weeks for 6 cycles of treatment |
| FAC (5-fluorouracil) | ACTIVE_COMPARATOR | 5-fluorouracil (500 mg/m\^2) in combination with doxorubicin (50 mg/m\^2) and cyclophosphamide (500 mg/m\^2) on day 1 every 3 weeks for 6 cycles of treatment |
| Docetaxel/Cisplatin/5-FU (TCF) | EXPERIMENTAL | * Docetaxel 75 milligrams per square meter (mg/m²) over 1 hour on Day 1 every 3 weeks * Cisplatin 75 mg/m² Day 1 over 6 hours every 3 weeks * 5-Fluorouracil 750 mg/m²/day continuous infusion Days 1 to 4 every 3 weeks as an induction therapy Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. |
| Cisplatin/5-FU (CF) | ACTIVE_COMPARATOR | * Cisplatin 80 mg/m² Day 1 over 6 hours every 3 weeks * 5-Fluorouracil 1000 mg/m²/day continuous infusion Day 1 to 4 every 3 weeks as an induction therapy. Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. |
| docetaxel plus cisplatin | EXPERIMENTAL | Taxotere 75 mg/m², one-hour IV infusion on Day 1 of each 3-week cycle followed by cisplatin 75 mg/m² administered as a 30-minute to 3-hour infusion on Day 1 |
| cisplatin plus 5-FU | ACTIVE_COMPARATOR | Cisplatin 100 mg/m², 30-minute to 3-hour infusion on Day 1 of each 3-week cycle followed by the continuous infusion of 5-FU 1000 mg/m²/day from Day 1 to Day 5 |
| docetaxel plus 5-FU | EXPERIMENTAL | Taxotere 85 mg/m², one-hour IV infusion on Day 1 of each 3-week cycle followed by the continuous infusion of 5-FU 750 mg/m²/day from Day 1 to Day 5 Arm only in the phase II part of the study |
| Name | Type | Description |
|---|---|---|
| Leucovorin | DRUG | Pharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV Dose regimen: |
| OXALIPLATIN | DRUG | Pharmaceutical form: Lyophilized powder for injection (50 mg/vial or 100 mg/vial) or aqueous solution (50 mg/10 mL and 100 mg/20 mL) Route of administration: IV Dose regimen: |
| 5-Fluorouracil | DRUG | Pharmaceutical form: vials of 5 g/100mL Route of administration: IV Dose regimen: |
| DOCETAXEL | DRUG | Intravenous |
| CISPLATIN | DRUG | Intravenous |
| Doxorubicin | DRUG | - |
| Cyclophosphamide | DRUG | - |
| docetaxel (XRP6976) | DRUG | - |
| 5-fluorouracil (5-FU) | DRUG | - |
Inclusion criteria: * Histologically or cytologically proven pancreatic carcinoma * Measurable locally advanced or metastatic disease * Patient previously treated with 5-FU as a "radiation sensitizer" and all toxicities must have been resolved * Patients must have received Gemcitabine-based chemoth...
5-Fluorouracil is used in oncology for the treatment of breast cancer, nasopharyngeal neoplasms, pancreatic neoplasms, head and neck neoplasms, and stomach neoplasms. It is a small molecule therapeutic being developed by Sanofi for these cancer indications.
5-Fluorouracil is a small molecule oncology drug. Its specific molecular target is not disclosed in the available clinical trial information. It is being studied in combination with docetaxel in several cancer types.
Sanofi (ticker: SNY) is the developer of 5-Fluorouracil. The drug is being investigated in clinical trials for multiple oncology indications including breast cancer and head and neck cancer.
5-Fluorouracil is in Phase 3 clinical development. It is an investigational drug for oncology indications and has not been reported as FDA approved in the available trial data. Two Phase 3 trials have been completed.
5-Fluorouracil has been studied in completed trials including NCT00401323 for head and neck squamous cell carcinoma, NCT00688740 for node positive adjuvant breast cancer, NCT00811447 for gastric cancer, and NCT00995293 for squamous cell carcinoma of the head and neck.
No, 5-Fluorouracil is not the same as docetaxel. The clinical trials listed under 5-Fluorouracil investigate docetaxel (Taxotere) in combination with 5-Fluorouracil for various cancers, but they are distinct drugs.