Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Oxaliplatin (Eloxatin®), Oxaliplatin (SR96669), Eloxatin
OXALIPLATIN · 29 trials · 22 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
Pathologic Complete Response rate: percentage of participants with response reported as Pathologic complete response (pathCR) following surgery. Once surgery performed, response to therapy judged in surgical specimen with three possible categories reported: 1) Pathologic complete response (no residual cancer in the specimen); 2) \<50% of residual cells in the surgical specimen; or 3) \>50% of cells in the surgical specimen. Upon recovery from chemoradiation (Chemo), surgery follows approximately 5-6 weeks later with response assessment. Arm A schedule consists of 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. Arm B schedule consist of 8 weeks of Chemo, followed by 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. In particular, Arm B is 8 weeks longer than Arm A.
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
The complete pathologic response (path CR) rate after treatment calculated as the percentage of participants with path CR out of the total participants, where the path CR is defined as absence of tumor cells in the surgical specimen and all registered participants are used in the denominator for calculating the path CR rate. Primary gastric carcinoma is not measurable by conventional criteria thus usual response criteria cannot be applied. The following criteria for response assessment applied: Pathologic Complete Response: Absence of tumor cells in the surgical specimen, 95% or more necrosis of the cancer; Complete Clinical Response: Absence of tumor on endoscopy, biopsy, cytology, or both.
| 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. |
| Arm A: Chemo with Radiation Treatment | EXPERIMENTAL | For 5 weeks, Chemo of 5-FU 250 mg/m\^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m\^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery. |
| Arm B: Pre-Op Chemo + Chemo with Radiation Treatment | EXPERIMENTAL | Pre-Operative Chemo 5-FU 2.2 mg/m\^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m\^2 IV on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A) |
| 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. |
| 5-Fluorouracil + Folinic Acid + Oxaliplatin | EXPERIMENTAL | PreOp Chemotherapy: 2 cycles (each cycle consisting of 4 weeks or 2 treatments) of chemotherapy with oxaliplatin, folinic acid and infusional 5-FU (FOLFOX-48). Oxaliplatin 100 mg/m\^2 over 2 hours on day 1, folinic acid intravenous (IV) at 200 mg/m\^2 over 30 minutes on day 1, and 5-FU 2,200 mg/m\^2 over 48 hours as continuous infusion by outpatient pump starting on day 1. This therapy, FOLFOX-48 repeated every 2 weeks x 4 (8 weeks of induction chemotherapy). PreOp Chemoradiotherapy begins 12 days after last dose of PreOp Chemo 5FU plus oxaliplatin; A total of 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m\^2/d Monday through Friday) \& weekly oxaliplatin 45 mg/m\^2 over 2 hours for 5 weeks (oxaliplatin administered on the first day of radiation week). Surgical resection 4-6 weeks after completion of chemoradiotherapy |
| 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 |
| Radiation Therapy | RADIATION | Radiation treatment every weekday for 5 weeks. |
| Surgery | PROCEDURE | Surgical removal of the primary tumor and lymph nodes following completion of disease status evaluation post chemotherapy and radiation treatments. |
| Folinic Acid | DRUG | 200 mg/m\^2 by vein Over 30 Minutes On Days 1, 15, 29, and 43. |
| Radiotherapy | RADIATION | 45 Gy (1.8 Gy fx/day) Monday through Friday, 12 days after the last dose of 5FU plus oxaliplatin and no later than 28 days. |
| 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 | - |
| bevacizumab | 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. |
| 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...
Oxaliplatin is a small molecule oncology drug studied in biliary tract neoplasms, bladder cancer, breast cancer, hepatocellular carcinoma, colonic neoplasms, and colorectal cancer. It is also studied in rectal, pancreatic, gastric, and endometrial cancers. It is given in combination regimens, including with capecitabine, 5-fluorouracil, irinotecan, bevacizumab, and docetaxel.
Oxaliplatin is developed by Sanofi, which trades under the ticker SNY. The drug is also known by the brand name Eloxatin and by the research code SR96669. It is a small molecule agent in the oncology therapeutic area.
Oxaliplatin is in Phase 2 development for the indications tracked here, and it is investigational rather than approved for those uses. Four trials are recorded, all completed, with no active trials. Total enrollment across those completed studies is 2,246 patients.
Completed oxaliplatin trials include NCT02694718, a Phase 2 study of capecitabine plus oxaliplatin with pre-operative pelvic radiotherapy in rectal cancer in Switzerland, and NCT01121848, a Phase 3 second-line pancreatic cancer study in Canada. NCT00952003 tested oxaliplatin, irinotecan, and bevacizumab followed by docetaxel and bevacizumab in gastric cancer, and NCT00612495 studied oxaliplatin alone and with 5FU in endometrial cancer.
Yes. Oxaliplatin is also known as Eloxatin, and it carries the research code SR96669. It is frequently identified by its combination partners in trial listings, including 5-FU, capecitabine, irinotecan, bevacizumab, docetaxel, cisplatin, leucovorin, paclitaxel, and radiotherapy, but these are regimen names rather than separate drugs.
Oxaliplatin is a small molecule oncology agent. It is studied both as a single agent and in combination regimens across gastrointestinal and other solid tumor types, including colorectal, rectal, pancreatic, gastric, and endometrial cancers, as well as biliary tract, bladder, breast, and hepatocellular cancers.