A Phase I Trial of Gemcitabine (Gemzar) Plus ABI-007 (ABRAXANE) 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the MTD and DLT of gemcitabine plus ABI-007 in patients with advanced metastatic pancreatic cancer.
Enrollment and treatment period 1 year
No
Daniel Von Hoff, MD
Principal Investigator
Scottsdale Clinical Research Institute
United States: Food and Drug Administration
CA040
NCT00398086
November 2006
December 2010
Name | Location |
---|---|
South Texas Oncology & Hematology | San Antonio, Texas 78207 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University | Baltimore, Maryland 21231 |
University of Alabama at Birmingham Comprehensive Cancer Ctr | Birmingham, Alabama |
Scottsdale Healthcare/Virginia Pipe Cancer Institute | Scottsdale, Arizona 85258 |
Virigina Piper Cancer Institute | Minneapolis, Minnesota 55407 |