drugset / Trial / NCT05825066
Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
Phase 2
Recruiting
64 enrolled
Wake Forest University Health Sciences
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
The objective of this research is to find out what effects (good and bad), the sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX, the standard chemotherapy for pancreatic cancer, has on participants and their condition. Gemcitabine - Abraxane (nab-Paclitaxel) and mFOLFIRINOX has been approved by the US Food and Drug Administration (FDA) as first line treatment for advanced pancreatic cancer. The sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX has not been approved by the FDA for treatment of pancreatic cancer.
Timeline
- Start
- 2023-08-01
- Primary completion
- 2027-06
- Completion
- 2028-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 150 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 125 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |