Age-Related Changes in Nanoparticle Albumin Bound (Nab) Paclitaxel Pharmacokinetics and Pharmacodynamics
- To determine age-related changes in the pharmacokinetics (pK) of weekly paclitaxel
albumin-stabilized nanoparticle formulation (nab-paclitaxel) in patients with
metastatic breast cancer.
- To determine age-related changes in the pharmacodynamics (toxicity) of nab-paclitaxel
in these patients.
- To determine response and time to progression in these patients.
- To explore predictors of pK parameters in these patients.
- To explore predictors of the need for dose reduction, dose delays, or grade 3 or 4
toxicity in these patients.
OUTLINE: Patients are stratified by age in years (< 50 vs 50-60 vs 60-70 vs > 70).
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes
once daily on days 1, 8, and 15 as planned. Treatment repeats every 28 days in the absence
of disease progression or unacceptable toxicity.
Blood is drawn for pharmacokinetic studies periodically during course 1.
Patients complete questionnaires regarding risk factors that would predict for
pharmacokinetic parameters at baseline, prior to the third course of treatment, and at end
of study. Data collected include medical characteristics, demographics, functional status,
comorbidity, psychological status, social functioning and support, nutritional status, and
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Age-related changes in the pharmacokinetics (pK)
Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours
Arti Hurria, MD
Beckman Research Institute
United States: Institutional Review Board
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|City of Hope Medical Group||Pasadena, California 91105|