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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109

More Details

Status
Recruiting
Sponsor
University of Michigan Rogel Cancer Center

Study Contact

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

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.