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Recruiting NCT05183126

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

Phase IV Interventional Breast Cancer Metastatic Gastric Cancer Esophageal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Paclitaxel, Paclitaxel.
Who it may be relevant to
Registry conditions: Breast Cancer, Metastatic Gastric Cancer, Esophageal Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

Paclitaxel is an FDA-approved and commonly used standard of care agent for patients with early-stage breast cancer. This study will use the standard dose of 80 mg/m\^2, including the typical pre-medications as per University of Michigan Rogel Cancer Center institutional standard. The only investigational component of this study is lengthening the infusion duration from 1-hour to 2 or 3 hours for a single dose in patients with low SMA.

JAN2025 update, Paclitaxel is an FDA-approved and commonly used standard of care agent for patients with early-stage breast cancer or metastatic gastric or esophageal cancers.

Interventions

  • Drug 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.
  • Drug 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 measures

  • Maximum concentration (Cmax) of paclitaxel plasma [Time frame: Up to week 12]
Secondary outcome measures (2)
  • Two- to three-hour Cmax vs. one-hour Cmax in low SMA patients [Time frame: Up to week 12]
  • One-hour Cmax in normal SMA patients vs. one-hour Cmax in low SMA patients [Time frame: Up to week 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Michigan Rogel Cancer Center — Ann Arbor

Identifiers

NCT: NCT05183126 · UMCC 2021.109 · HUM00207945

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗