Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer
Start Date
3/28/2022
Completion Date
11/1/2026
Summary
The primary objective of this pharmacokinetics study is to compare the maximum concentration level of paclitaxel in patients with low/sarcopenic skeletal muscle area (SMA), at the end of a 2-3 hour paclitaxel infusion, to the maximum level in patients with normal SMA at the end of a standard 1-hour infusion with the goal of determining whether lengthening the infusion in patients with low/sarcopenic SMA normalizes the levels to those of patients with normal SMA.
Detailed Description
Paclitaxel is an FDA-approved and commonly used standard of care agent for patients with early-stage breast cancer. This study will use the standard dose of 80 mg/m\^2, including the typical pre-medications as per University of Michigan Rogel Cancer Center institutional standard. The only investigational component of this study is lengthening the infusion duration from 1-hour to 2 or 3 hours for a single dose in patients with low SMA. JAN2025 update, Paclitaxel is an FDA-approved and commonly used standard of care agent for patients with early-stage breast cancer or metastatic gastric or esophageal cancers.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Paclitaxel
Paclitaxel
Conditions
Locations
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
United States