BrUOG 278:FOLFOX-A For Pancreatic Cancer :A Brown University Oncology Research Group Study
More active treatments are desperately needed in pancreatic cancer. The regimen of
FOLFIRINOX increases survival as compared to gemcitabine but at a cost of increased
toxicity. Irinotecan is responsible for much of the toxicity of FOLFIROX but may not
contribute significantly to the regimen's activity. Abraxane is a new agent in pancreatic
cancer. This albumin-bound nanoparticle form of paclitaxel increases tumor accumulation of
paclitaxel though binding of albumin to SPARC in pancreatic cancer stroma. The investigators
therefore propose a pilot study of FOLFOX (fluorouracil, leucovorin and oxaliplatin)
combined with abraxane to establish the safety and preliminary activity of FOLFOX-A.
Patients with inoperable (metastatic and locally advanced) pancreatic cancer will be
eligible since the primary outcome is to establish the safety of FOLFOX-A.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity of FOLFOX-Abraxane (A) for patients with newly diagnosed, advanced pancreatic cancer.
For up to 30 days post completing drug, an expected average of 6 months
Howard Safran, MD
United States: Food and Drug Administration
|Rhode Island Hospital||Providence, Rhode Island 02903|
|The Miriam Hospital||Providence, Rhode Island 02903|
|Memorial Hospital||Pawtucket, Rhode Island 02860|