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Paclitaxel Infusion Study for Breast, Gastric, and Esophageal Cancers

This study is looking at how the chemotherapy drug paclitaxel (an FDA-approved treatment for breast, metastatic gastric, and esophageal cancers) is processed in the body. Specifically, it aims to see if changing the infusion time for paclitaxel can help patients with lower skeletal muscle area (SMA) achieve similar drug levels as those with normal SMA. You might be eligible if you are an adult woman with one of these cancers and are planned to receive paclitaxel. The study will measure the highest level of paclitaxel in your blood to see if longer infusion times help normalize these levels. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 22 participants. It will compare different paclitaxel infusion durations.
What's involved
You would receive weekly intravenous infusions of paclitaxel for a total of 12 weeks. For one dose (between doses 2-12), your infusion time might be lengthened to 2 or 3 hours.
Compensation
Not stated in the trial record.
Follow-up
The primary measurement of paclitaxel levels will be taken up to week 12.

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NCT05183126

Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer

Recruiting
PHASE4Ages 18+InterventionalTreatment
University of Michigan Rogel Cancer Center
~22 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Paclitaxel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum concentration (Cmax) of paclitaxel plasma
Measured over Up to week 12

Conditions

Breast Cancer
Metastatic Gastric Cancer
Esophageal Cancer

Explore related trials

Breast CarcinomaEsophageal CarcinomaGastric Carcinoma

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Daniel L Hertz, PharmD, PhD · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center

Who to contact

Cancer AnswerLine
[email protected]
800-865-1125
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Maximum concentration (Cmax) of paclitaxel plasmaUp to week 12

    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.