RecruitingPhase 4NCT05183126

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

Sponsor

University of Michigan Rogel Cancer Center

Enrollment

22 participants

Start Date

Mar 28, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Esophageal Cancer Metastatic Gastric Cancer

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pharmacokinetic study (how the body absorbs and processes a drug) is examining whether using a patient's muscle mass (measured by a CT scan) to calculate the dose of paclitaxel — a common chemotherapy drug — leads to better dosing accuracy compared to the standard method of using body surface area. **You may be eligible if:** - You are a woman 18 years or older - You are scheduled to receive paclitaxel at the standard dose (80 mg/m²) as a 1-hour infusion for cancer treatment - You have had a CT, PET-CT, or MRI scan of the chest, abdomen, or pelvis within the past year - Your organ function is adequate to receive paclitaxel treatment **You may NOT be eligible if:** - You are taking certain medications that strongly interact with the liver enzyme CYP2C8 (such as rifampin or clopidogrel) - You have had a serious allergic reaction to paclitaxel in the past - You are pregnant or nursing - Your paclitaxel dose or infusion rate has been modified for any reason Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPaclitaxel

Weekly intravenous (IV) infusion of a standard dose of paclitaxel 80 mg/m\^2. Dose 1 is a 90-minute infusion. All other doses administered as a 1-hour infusion for a total of 12 weekly doses.

DRUGPaclitaxel

Weekly intravenous (IV) infusion of a standard dose of paclitaxel 80 mg/m\^2. Dose 1 is a 90-minute infusion. During doses 2-12, patients with low SMA will receive one 2-hour infusion and patients with sarcopenic SMA will receive one 3-hour infusion. All other doses during weeks 2-12 are standard infusion time.