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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Paclitaxel
DrugWeekly 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.
Paclitaxel
DrugWeekly 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.
Treatment groups
22 Participants
are divided into 2 treatment groupsGroup A: Normal SMA (>7310 mm^2)Active comparator 1 intervention
Group B: Low SMA (5120 - 7310 mm^2) and Sarcopenic SMA (<5120 mm^2)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum concentration (Cmax) of paclitaxel plasma
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.
Time frame
Up to week 12Secondary outcomes
1
Two- to three-hour Cmax vs. one-hour Cmax in low SMA patients
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. 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.
Time frame
Up to week 122
One-hour Cmax in normal SMA patients vs. one-hour Cmax in low SMA patients
To compare Cmax in patients with lower SMA versus patients with normal SMA receiving when both receive standard 1-hour infusion. Blood samples for pharmacokinetic analysis will be collected within 5 minutes prior to the end of standard 1-hour paclitaxel infusions in both groups. Measurement of plasma paclitaxel concentration for Cmax will be conducted using a liquid chromatography/mass spectroscopy assay.
Time frame
Up to week 12Sponsors and contacts
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Source ClinicalTrials.gov