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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05183126
• Other study ID #: UMCC 2021.109
• Secondary ID: HUM00207945
• Status: Recruiting
• Phase: Phase 4
• Start date: March 28, 2022
• Est. completion date: May 2024

Study information

• Verified date: January 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: Cancer AnswerLine
• Phone: 800-865-1125
• Email: CancerAnswerLine[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stage 1-3 breast cancer
• Planned neoadjuvant, adjuvant, or curative intent paclitaxel 80 mg/m^2, 1-hour infusion (note: combination treatment, e.g., trastuzumab, pertuzumab, carboplatin, or pembrolizumab, and prior treatment, e.g., doxorubicin and cyclophosphamide, are allowable.
• Evaluable computed tomography (CT) scan, e.g., scan of the chest, abdomen, or pelvis for any indication within 1 year.
• Adequate organ function based on paclitaxel label.
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum concentration (Cmax) of paclitaxel plasma	Compare Cmax in patients with lower SMA with an adjusted infusion duration (i.e., 2-hour or 3-hour) to that of patients with normal SMA receiving standard 1-hour infusion. Blood samples for pharmacokinetic analysis will be collected within 5 minutes prior to the end of SMA-based and standard paclitaxel infusions. Measurement of plasma paclitaxel concentration for Cmax will be conducted using a liquid chromatography/mass spectroscopy assay.	Up to week 12
Secondary	Two- to three-hour Cmax vs. one-hour Cmax in low SMA patients	To compare Cmax in patients with lower SMA when receiving adjusted infusion duration (i.e., 2-hour or 3-hour) versus standard 1-hour infusion. Blood samples for pharmacokinetic analysis will be collected within 5 minutes prior to the end of SMA-based and standard paclitaxel infusions. Measurement of plasma paclitaxel concentration for Cmax will be conducted using a liquid chromatography/mass spectroscopy assay.	Up to week 12
Secondary	One-hour Cmax in normal SMA patients vs. one-hour Cmax in low SMA patients	To compare Cmax in patients with lower SMA versus patients with normal SMA receiving when both receive standard 1-hour infusion. Blood samples for pharmacokinetic analysis will be collected within 5 minutes prior to the end of standard 1-hour paclitaxel infusions in both groups. Measurement of plasma paclitaxel concentration for Cmax will be conducted using a liquid chromatography/mass spectroscopy assay.	Up to week 12