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

Launched by UNIVERSITY OF MICHIGAN ROGEL CANCER CENTER · Dec 20, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating how the drug paclitaxel, which is commonly used to treat breast cancer, behaves in patients with different amounts of muscle mass. The study aims to find out if giving paclitaxel over a longer period (2-3 hours) to patients with less muscle can help normalize the drug levels in their bodies to match those of patients with normal muscle mass who receive the drug over a shorter time (1 hour). This research is important because it could lead to better treatment strategies for those with lower muscle mass, which may affect how their bodies process medication.

To be eligible for this trial, participants must be female, aged between 65 and 74 years, and diagnosed with stage 1 to 3 breast cancer. They should be scheduled to receive paclitaxel as part of their treatment plan. Participants must also have recent imaging scans to check their condition and must be in good overall health. During the trial, participants will receive paclitaxel and will be monitored to see how well their bodies handle the medication. It's also essential to note that individuals who are pregnant, nursing, or have specific allergies to paclitaxel cannot participate in the study. This research could ultimately help improve treatment outcomes for patients with breast cancer.

Gender

FEMALE

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