This randomized phase I trial studies the side effects and best dose of nanosomal docetaxel lipid suspension in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as nanosomal docetaxel lipid suspension, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PRIMARY OBJECTIVES: I. To assess the pharmacokinetics profile of nanosomal docetaxel lipid suspension (NDLS) in patients with advanced solid tumors. SECONDARY OBJECTIVES: I. To assess the safety and toxicity of NDLS in patients with advanced solid tumors. OUTLINE: Patients are randomized to 1 of 4 treatment arms. ARM I: Patients receive lowest dose nanosomal docetaxel lipid suspension intravenously (IV) over 1 hour. ARM II: Patients receive low dose nanosomal docetaxel lipid suspension IV over 1 hour. ARM III: Patients receive high dose nanosomal docetaxel lipid suspension IV over 1 hour. ARM IV: Patients receive highest dose nanosomal docetaxel lipid suspension IV over 1 hour. In all arms, treatment may repeat every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Given IV
Correlative studies
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Pharmacokinetic profile of nanosomal docetaxel lipid suspension
Descriptive statistics of all pharmacokinetic parameters would be computed and reported for free and total docetaxel. Maximum blood concentration (Cmax), area under the curve (AUC)0-t, AUC0-infinity, time to Cmax (Tmax), terminal elimination rate constant (lambda z), half-life (t1/2), AUC percent extrapolated (%Extrap), clearance (CL), and volume of distribution (Vd) will be calculated.
Time frame: Pre-dose and post dose at 10, 20, 30, 40, 50, 60, 80, and 100 minutes and 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, and 48 hours
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