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Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer

RecruitingPhase 4Ages 18 Years - anyFemaleUniversity of Michigan Rogel Cancer Center
NCT05183126 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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) * Female * ≥ 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
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What it tests

  • Paclitaxel
  • Paclitaxel
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Where

1 site
University of Michigan Rogel Cancer Center
Ann Arbor, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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