RATIONALE: Drugs used in chemotherapy, such as paclitaxel and ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining paclitaxel with ABI-007 may kill more tumor cells. PURPOSE: Randomized phase I trial to study the effectiveness of combining paclitaxel with ABI-007 in treating patients who have locally advanced or metastatic solid tumors.
OBJECTIVES: Primary * 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. Secondary * 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 these patients. * 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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
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