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
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Infusions
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The only investigational component of this study is lengthening the infusion duration from 1-hour to 2 or 3 hours for a single dose in patients with low SMA."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this 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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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
Study sites (1)
MI
- University of Michigan Rogel Cancer Center · Ann Arbor, MI 48109Daniel L Hertz, PharmD, PhD · Principal investigatorMore trials in Ann Arbor