Randomized, Crossover, Pharmacokinetic Study Of Paclitaxel (Taxol) And ABI-007 (A Cremophor EL-Free, Protein Stabilized, Nanoparticle Paclitaxel) In Patients With Advanced Solid Tumors
- Determine whether a change in the formulation alters the pharmacokinetic profile of
paclitaxel in the plasma of patients with incurable locally advanced or metastatic
solid tumors treated with ABI-007 and paclitaxel.
- Correlate pharmacokinetic data of this regimen with decrease in the neutrophil count at
nadir in these patients.
- Determine the intra- and interindividual pharmacokinetic variability of ABI-007 in
- Determine protein binding of paclitaxel via measurement of α-1-acid glycoprotein and
serum albumin levels in patients treated with this regimen.
OUTLINE: This is a randomized, pilot study.
- Courses 1 and 2: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours on day 1 and ABI-007 IV over 30
minutes on day 22.
- Arm II: Patients receive ABI-007 IV over 30 minutes on day 1 and paclitaxel IV
over 3 hours on day 22.
- Courses 3 and beyond: All patients receive ABI-007 IV over 30 minutes on day 1. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Primary Purpose: Treatment
William D. Figg, PharmD
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|