Recruiting

Paclitaxel

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT05183126

Conditions

Breast Cancer

Metastatic Gastric Cancer

Esophageal Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Paclitaxel

Paclitaxel

Study Details

Brief 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.

Conditions

Breast Cancer

Metastatic Gastric Cancer

Esophageal Cancer

Study ID

NCT05183126

Start date

Mar 28, 2022

Status verified date

Jul, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

22 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Paclitaxel

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.

Paclitaxel

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.

Primary outcome measure

  • Maximum concentration (Cmax) of paclitaxel plasma [ Time Frame: Up to week 12 ]

Central Contacts and Locations

Central contacts

Cancer AnswerLine

800-865-1125CancerAnswerLine@med.umich.edu

Locations

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator:

Daniel L Hertz, PharmD, PhD

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Jul 2, 2026

Last verified

Jul, 2026

Keywords

  • pharmacokinetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-07-02.