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

Sponsor

University of Michigan Rogel Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05183126

Collaborator

(none)

Enrollment

Location

Arms

18.1

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Paclitaxel Drug: Paclitaxel	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 28, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Normal SMA (>7310 mm^2) Standard paclitaxel infusion time.	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. Other Names: Taxol
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.	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. Other Names: Taxol

Arm

Intervention/Treatment

Active Comparator: Normal SMA (>7310 mm^2)

Standard paclitaxel infusion time.

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.

Other Names:

Taxol

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.

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.

Other Names:

Taxol

Outcome Measures

Primary Outcome Measures

Maximum concentration (Cmax) of paclitaxel plasma [Up to week 12]
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.

Secondary Outcome Measures

Two- to three-hour Cmax vs. one-hour Cmax in low SMA patients [Up to week 12]
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.
One-hour Cmax in normal SMA patients vs. one-hour Cmax in low SMA patients [Up to week 12]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan Rogel Cancer Center

Investigators

Principal Investigator: Daniel L Hertz, PharmD, PhD, University of Michigan Rogel Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Michigan Rogel Cancer Center

ClinicalTrials.gov Identifier:

NCT05183126

Other Study ID Numbers:

UMCC 2021.109
HUM00207945

First Posted:

Jan 10, 2022

Last Update Posted:

Jul 19, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Michigan Rogel Cancer Center

pharmacokinetics

Additional relevant MeSH terms:

Breast Neoplasms

Paclitaxel

Albumin-Bound Paclitaxel

Study Results

No Results Posted as of Jul 19, 2022