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Also known as Oxaliplatin, 5-FU, Oxaliplatin (Eloxatin®), Oxaliplatin, Paclitaxel, Oxaliplatin (SR96669), Oxaliplatin, 5-Fluorouracil, Oxaliplatin, capecitabine, oxaliplatin, 5 FU, Oxaliplatin, capecitabine, radiotherapy
OXALIPLATIN · 28 trials · 20 indications
PFS is defined as the time from the start of treatment to the date of disease progression or death from any cause.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Subjects once off treatment wil be followed for survival
Pathological complete tumor response was defined as grade 3 or 4 in the histological grading of regression according to Dworak classification. Grade 0 is no regression; Grade 1 is dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2 is dominantly fibrotic changes with few tumor cells or groups; Grade 3 is defined as very few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance; Grade 4 is defined as no tumor cells, only fibrotic mass (total regression or response).
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
| 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. |
| A | EXPERIMENTAL | Oxaliplatin + 5-Fluorouracil/Leucovorin |
| B | ACTIVE_COMPARATOR | Doxorubicin |
| 1 | ACTIVE_COMPARATOR | Capecitabine + Oxalipatin |
| 2 | NO_INTERVENTION | - |
| Intervention | EXPERIMENTAL | Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. |
| Oxaliplatin and Taxotere | EXPERIMENTAL | Patients will receive both docetaxel and oxaliplatin, IV on day 1 of each cycle. Treatment will be repeated every 21 days for up to 6 courses in the absence of disease progression, unacceptable toxicity, or \>50% increase in serum PSA. |
| interventional arm | EXPERIMENTAL | Oxaliplatin, Irinotecan and Bevacizumab for 3 cycles followed by Docetaxel and Bevacizumab for a further 3 cycles. Upon completion of the combination therapy cycles Bevacizumab will be continued until progression. |
| Capecitabine+Oxaliplatin | EXPERIMENTAL | Eligible participants received capecitabine 1000 milligrams per square meter (mg/m\^2) on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14. |
| Oxaliplatin/Capecitabine | EXPERIMENTAL | All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle. |
| Single arm | EXPERIMENTAL | - |
| Oxaliplatin | EXPERIMENTAL | - |
| 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: |
| Oxaliplatin + 5-Fluorouracil/Leucovorin | DRUG | Day 1: Oxaliplatin 85mg/m² 2h IV infusion, leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m2 22h IV infusion. Day 2: Leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m² 22h IV infusion. Repeated every 2 weeks |
| Doxorubicin | DRUG | Day 1: Doxorubicin 50mg/m² iv infusion. Repeated every 3 weeks. |
| Capecitabine | DRUG | 1,000 mg/m² twice daily. Film coated tablets of 500 mg, 150mg. |
| irinotecan hydrochloride | DRUG | - |
| Oxaliplatin (SR96669) | DRUG | - |
| Trastuzumab | DRUG | Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes. |
| Taxotere | DRUG | - |
| Oxaliplatin, Irinotecan, Bevacizumab, Docetaxel | DRUG | - |
| Fluorouracil | DRUG | 400mg/m², 2 hours IV bolus, Day 1; 22 hours continuous IV infusion 600mg/m², Day 1 and Day 2; Every 2 weeks |
| Oxaliplatin, capecitabine | DRUG | OXA 130 D1 + Capecitabine 2000 / day D1-D14 for 4 cycles. After 10 weeks of rest, XELOX-RT regimen x 5 weeks followed by surgery |
| bevacizumab | DRUG | 10mg/kg IV on Day 1 Q 2 weeks |
| gemcitabine | DRUG | 1000mg/m2 as fixed-rate infusion at 10mg/m2/min on Day 1 and Q 2 weeks. |
| Oxaliplatin, capecitabine, radiotherapy | DRUG | * Oxaliplatin 50mg/m² I.V. 2 hours weekly x 5 doses * Capecitabine 825mg/m² P.O. B.I.D. daily x 5 days x 5 weeks * Radiotherapy 45 Gy total (1.8Gy/dose) 25 fractions daily x 5 days x 5 weeks |
| fluoropyrimidine | DRUG | - |
| Oxaliplatin, 5-Fluorouracil | DRUG | 5FU 500 mg/m² per week in IV bolus infusion during 30 min AF 20mg/m²/week in infusion, during 10-20 minutes prior 5FU infusion; Eloxatin 85 mg/m² as IV infusion 2-6 hours, every 2 weeks. Three weeks of treatment, one week rest. |
| Radiotherapy | RADIATION | Planned total dose of 45-50.4Gy (with cone down) in 25-28 fractions |
| oxaliplatin, 5 FU | DRUG | Oxaliplatin:130 mg/m² as a 2-hour intravenous (IV) infusion in 500 mL of 5% glucose solution on Day 1 and repeated every 3 weeks. 5-FU: following oxaliplatin administration, 1000 mg/m²/day as a continuous IV infusion from Day 1 to Day 4, repeated every 3 weeks. |
| Oxaliplatin, Paclitaxel | DRUG | Oxaliplatin was provided in clear glass vials sealed with a rubber stopper and an aluminum seal with a flip-off cover. Each vial contained 50 or 100 mg of active ingredient with 450 or 900 mg, respectively, of lactose monohydrate as excipient Paclitaxel was supplied as single dose vials of 30 mg/5 mL or 100 mg/17 mL. |
| Oxaliplatin, 5-FU | DRUG | Oxaliplatin: 130 mg/m² in 500 mL of 5% glucose solution as a 2-hour intravenous (IV) infusion on Day 1 and repeated every 3 weeks; 5-FU: following oxaliplatin administration, 1000 mg/m²/day as a continuous IV infusion from Day 1 toDay 4, every 3 weeks.Dose adjustments were made if the patient experienced AEs. |
| Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU) | DRUG | OXALIPLATIN 60 mg/m2/d, CISPLATIN 55 mg/m2/d, 5-FU 600 mg/m2/d with dose range and followed by radiotherapy |
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...