Home › Breast Cancer › NCT05183126
Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer
Phase IV Single-arm Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer
Who can join
Ages 18 and older · Women
Full eligibility criteria
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
About the study
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.
What is being tested
- Paclitaxel (drug)
- Paclitaxel (drug)
Sponsor: University of Michigan Rogel Cancer Center · Participants: 22 · Started: Mar 28, 2022
Contact the study team
- Cancer AnswerLine · Phone: 800-865-1125
Official record on ClinicalTrials.gov — NCT05183126
Locations in the U.S.
| Michigan | University of Michigan Rogel Cancer Center, Ann Arbor |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.