Comparing Paclitaxel Infusion Durations in Cancer Patients with Low Muscle Mass
Phase IV Single-arm Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer
This study is testing if giving paclitaxel over a longer time helps cancer patients with low muscle mass have better drug levels in their system compared to those with normal muscle mass.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05183126 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older with breast cancer, metastatic gastric cancer, or esophageal cancer who are scheduled to receive a standard paclitaxel infusion.
Not a fit: Patients with a history of hypersensitivity to paclitaxel or those receiving different doses or infusion rates will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could optimize paclitaxel treatment for patients with low muscle mass, potentially improving therapeutic outcomes.
How similar studies have performed: While this specific approach is novel, similar pharmacokinetic studies have shown promise in optimizing drug delivery based on patient-specific factors.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.