Metastatic Pancreatic Cancer Clinical Trial
Official title:
A Phase I Trial of Gemcitabine (Gemzar) Plus ABI-007 (ABRAXANE) In Patients With Advanced Metastatic Pancreatic Cancer
To determine the maximum tolerated dose and dose-limiting toxicity of Gemcitabine plus Albumin-bound paclitaxel (ABI-007) in patients with advanced metastatic pancreatic cancer.
Albumin-bound paclitaxel is a novel, solvent-free, albumin-bound, 130 nanometer particle form
of paclitaxel designed to avoid the problems associated with solvents used in Taxol(Abraxane
prescribing information 2005). Albumin has a number of properties that make it an attractive
molecule to combine with paclitaxel. Albumin is a natural transporter of endogenous
hydrophobic molecules such as water-insoluble vitamins and hormones (Vorum 1999)and albumin
binding to the gp-60 receptor (albondin) initiates the caveolae-mediated endothelial
transport of protein-bound and unbound plasma constituents (John et al 2003, Minshall et al
2003, Tiruppathi et al 1997).
This study consisted of a Phase 1 dose escalation phase, a Phase 2 treatment phase and a
24-month follow-up phase.
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