This phase IV trial investigates the effect of paclitaxel infusion time (how slow or quickly drug is given) on the concentration of paclitaxel in the body in patients with cancer undergoing treatment with paclitaxel. Paclitaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. This study is trying to determine whether dosing the drug more slowly in some patients would decrease the amount of drug in their body at the end of infusion. Information from this study may help doctors understand how best to dose paclitaxel to avoid toxicity.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05183126.
Locations matching your search criteria
United States
Michigan
Ann Arbor
University of Michigan Rogel Cancer CenterStatus: Active
Contact: Daniel L. Hertz
Phone: 734-763-0015
PRIMARY OBJECTIVE:
I. Compare maximum concentration (Cmax) in patients with lower skeletal muscle area (SMA) with an adjusted infusion duration (i.e., 2-hour or 3-hour) to that of patients with normal SMA receiving standard 1-hour infusion.
SECONDARY OBJECTIVES:
I. To compare Cmax in patients with lower SMA when receiving adjusted infusion duration (i.e., 2-hour or 3-hour) versus standard 1-hour infusion.
II. To compare Cmax in patients with lower SMA versus patients with normal SMA receiving when both receive standard 1-hour infusion.
OUTLINE: Patients are assigned to 1 of 3 groups.
GROUP I (NORMAL SMA): Patients receive paclitaxel intravenously (IV) over 1 hour per standard of care. Patients undergo magnetic resonance imaging (MRI) or computed tomography (CT) scan, and/or positron emission tomography (PET) scan during screening and blood sample collection on study.
GROUP II (LOW SMA): Patients receive paclitaxel IV over 2 hours for 1 dose. Patients undergo MRI or CT scan, and/or PET scan during screening and blood sample collection on study.
GROUP III (SARCOPENIC SMA): Patients receive paclitaxel IV over 3 hours for 1 dose. Patients undergo MRI or CT scan, and/or PET scan during screening and blood sample collection on study.
Lead OrganizationUniversity of Michigan Rogel Cancer Center
Principal InvestigatorDaniel L. Hertz
