drugset / Trial / NCT01964287
First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma.
NaSingle-groupOpen-labelTreatment
Summary
Based on conventional chemotherapy approach, data have indicated that the Folfirinox regimen is more effective and tolerate than the treatment by Gemcitabine alone in patients with metastatic pancreatic adenocarcinoma. A recent study combining gemcitabine and nab paclitaxel improve the objective response rate. Primary objective of this study is to identify the maximun tolerated dose and the recommended phase II dose of first line treatment combining gemcitabine plus nab-paclitaxel followed by folfirinox in metastatic pancreatic adenocarcinoma.
Timeline
- Start
- 2013-09-24
- Primary completion
- 2016-12-22
- Completion
- 2020-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | — |
| Subject | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | — |