Back to resultsPharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Breast Cancer
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring pharmacokinetics
Eligibility Criteria
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
Sites / Locations
- University of Michigan Rogel Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Normal SMA (>7310 mm^2)
Low SMA (5120 - 7310 mm^2) and Sarcopenic SMA (<5120 mm^2)
Arm Description
Standard paclitaxel infusion time.
Adjusted paclitaxel infusion time during only one dose; standard paclitaxel infusion time for all other doses.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05183126
First Posted
December 20, 2021
Last Updated
August 4, 2023
Sponsor
University of Michigan Rogel Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05183126
Brief Title
Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Breast Cancer
Official Title
Phase IV Single-arm Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal SMA (>7310 mm^2)
Arm Type
Active Comparator
Arm Description
Standard paclitaxel infusion time.
Arm Title
Low SMA (5120 - 7310 mm^2) and Sarcopenic SMA (<5120 mm^2)
Arm Type
Experimental
Arm Description
Adjusted paclitaxel infusion time during only one dose; standard paclitaxel infusion time for all other doses.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
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 Information:
Title
Maximum concentration (Cmax) of paclitaxel plasma
Description
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.
Time Frame
Up to week 12
Secondary Outcome Measure Information:
Title
Two- to three-hour Cmax vs. one-hour Cmax in low SMA patients
Description
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.
Time Frame
Up to week 12
Title
One-hour Cmax in normal SMA patients vs. one-hour Cmax in low SMA patients
Description
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.
Time Frame
Up to week 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cancer AnswerLine
Phone
800-865-1125
Email
CancerAnswerLine@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel L Hertz, PharmD, PhD
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel L Hertz, PharmD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Breast Cancer
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