Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Michigan Rogel Cancer Center
About this trial
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.
Eligibility criteria
Qualifiers
Planned paclitaxel 80 mg/m², 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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Paclitaxel
- Paclitaxel
Treatment groups
22 Participants
are divided into 2 treatment groupsLocations
1University of Michigan Rogel Cancer Center48109, Ann ArborMichigan, United States
Sponsors and collaborators
University of Michigan Rogel Cancer Center
Lead sponsor
Source ClinicalTrials.gov