Phase IV Single-arm Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer

Who is this study for? Patients with breast cancer
What treatments are being studied? Paclitaxel
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
University of Michigan Rogel Cancer Center
RECRUITING
Ann Arbor
Contact Information
Primary
Cancer AnswerLine
CancerAnswerLine@med.umich.edu
800-865-1125
Time Frame
Start Date: 2022-03-28
Estimated Completion Date: 2025-12
Participants
Target number of participants: 22
Treatments
Active_comparator: Normal SMA (>7310 mm^2)
Standard paclitaxel infusion time.
Experimental: Low SMA (5120 - 7310 mm^2) and Sarcopenic SMA (<5120 mm^2)
Adjusted paclitaxel infusion time during only one dose; standard paclitaxel infusion time for all other doses.
Sponsors
Leads: University of Michigan Rogel Cancer Center

This content was sourced from clinicaltrials.gov

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