Comparing Paclitaxel Infusion Durations in Cancer Patients with Low Muscle Mass

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the pharmacokinetics of paclitaxel by comparing the maximum concentration levels in patients with low or sarcopenic skeletal muscle area (SMA) after a 2-3 hour infusion to those with normal SMA after a standard 1-hour infusion. The goal is to determine if extending the infusion duration for patients with low SMA can normalize drug levels to those seen in patients with normal SMA. Participants will receive the standard dose of 80 mg/m² of paclitaxel, with the only investigational aspect being the lengthened infusion time. The study is conducted at the University of Michigan Rogel Cancer Center.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Michigan Rogel Cancer Center
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Daniel L Hertz, PharmD, PhD — University of Michigan Rogel Cancer Center
• Study coordinator: Cancer AnswerLine
• Email: CancerAnswerLine@med.umich.edu
• Phone: 800-865-1125

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.