Study on Adjusting Paclitaxel Infusion Time Based on Muscle Mass in Breast Cancer Patients

Sponsor: University of Michigan Rogel Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05183126

Provider View

This study is exploring whether extending the infusion time of the chemotherapy drug paclitaxel can help achieve better drug levels in breast cancer patients with lower muscle mass, compared to those with normal muscle mass.

Patient Parameters

Program Overview

The main goal of this study is to see if extending the infusion time of paclitaxel from 1 hour to 2-3 hours in breast cancer patients with low muscle mass can help reach similar drug levels as those in patients with normal muscle mass. Paclitaxel is a common treatment for early-stage breast cancer, and this study will use the standard dose. The only change is the longer infusion time for patients with lower muscle mass.

Description

Paclitaxel is a chemotherapy drug approved by the FDA and commonly used to treat early-stage breast cancer. In this study, patients will receive the standard dose of 80 mg/m², along with the usual pre-medications as per the University of Michigan Rogel Cancer Center's guidelines. The study is investigating whether extending the infusion time from 1 hour to 2 or 3 hours for patients with lower muscle mass can help achieve drug levels similar to those in patients with normal muscle mass. This adjustment is the only experimental part of the study.

Eligibility Criteria

Inclusion Criteria

  • Have stage 1-3 breast cancer.
  • Plan to receive paclitaxel treatment with a standard dose of 80 mg/m², typically given over 1 hour. This can be part of a combination treatment with other drugs like trastuzumab or carboplatin, and after previous treatments like doxorubicin.
  • Have a CT scan of the chest, abdomen, or pelvis within the past year.
  • Have adequate organ function as required for paclitaxel treatment.
  • Be able to understand and willing to sign a consent form.

Exclusion Criteria

  • Taking medications that strongly affect the enzyme CYP2C8, such as rifampin or clopidogrel.
  • Have had allergic reactions to paclitaxel or its components that prevent continued treatment.
  • Are pregnant or breastfeeding.

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