NCT05183126 · University of Michigan Rogel Cancer Center
Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer
What this study is about
The primary objective of this how the drug moves through the body 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.
View original scientific description
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.
Interventions
DRUG
Paclitaxel
Weekly intravenous (IV) infusion of a standard dose of paclitaxel 80 mg/m\^2. Dose 1 is a 90-minute infusion. All other doses administered as a 1-hour infusion for a total of 12 weekly doses.
DRUG
Paclitaxel
Weekly intravenous (IV) infusion of a standard dose of paclitaxel 80 mg/m\^2. Dose 1 is a 90-minute infusion. During doses 2-12, patients with low SMA will receive one 2-hour infusion and patients with sarcopenic SMA will receive one 3-hour infusion. All other doses during weeks 2-12 are standard infusion time.
Primary outcome measures
Maximum concentration (Cmax) of paclitaxel plasma
Time frame: Up to week 12
Compare Cmax in patients with lower 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. Blood samples for pharmacokinetic analysis will be collected within 5 minutes prior to the end of SMA-based and standard paclitaxel infusions. Measurement of plasma paclitaxel concentration for Cmax will be conducted using a liquid chromatography/mass spectroscopy assay.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Planned paclitaxel 80 mg/m\^2, 1-hour infusion
- Evaluable computed tomography (CT) scan, positron emission tomography computed tomography (PET-CT) scan, or MRI scan (e.g. scan of the chest, abdomen, or pelvis for any indication w/in 1 year)
- ≥ 18 years old
- Adequate organ function to receive paclitaxel treatment as defined in the protocol
- Ability to understand and the willingness to sign a written informed consent
Exclusion criteria
- Concomitant administration of any moderate or strong inducer or inhibitor of CYP2C8, including rifampin or clopidogrel.
- History of hypersensitivity reaction to paclitaxel or any components of paclitaxel (e.g., Cremophor EL) that precludes continued treatment with standard dose and infusion length
- Pregnant or nursing
- Receiving any other dose (i.e., not 80 mg/m2) or infusion rate (i.e., not 60 minute infusion) either due to toxicity during a previous cycle or any other reason
Where
- Ann Arbor, Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations