Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
NCT05183126

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

Led by University of Michigan Rogel Cancer Center · Updated on 2026-03-06

22

Participants Needed

1

Research Sites

218 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Planned paclitaxel 80 mg/m^2, 1-hour infusion
  • Evaluable CT, PET-CT, or MRI scan of chest, abdomen, or pelvis within 1 year
  • Female
  • Age 18 years or older
  • Adequate organ function to receive paclitaxel as per protocol
  • Ability and willingness to sign informed consent
Not Eligible

You will not qualify if you...

  • Use of moderate or strong CYP2C8 inducers or inhibitors (e.g., rifampin, clopidogrel)
  • History of hypersensitivity to paclitaxel or its components preventing standard treatment
  • Pregnant or nursing
  • Receiving paclitaxel at a different dose or infusion rate than 80 mg/m^2 over 1 hour due to toxicity or other reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

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Research Team

C

Cancer AnswerLine

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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