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

University of Michigan Rogel Cancer Center

Status and phase: Enrolling; Phase 4

Conditions: Breast Cancer; Esophageal Cancer; Metastatic Gastric Cancer

Treatments: Drug: Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT05183126

UMCC 2021.109

HUM00207945 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Normal SMA (>7310 mm^2)

Active Comparator group

Description:

Standard paclitaxel infusion time.

Treatment:

Drug: Paclitaxel

Drug: Paclitaxel

Low SMA (5120 - 7310 mm^2) and Sarcopenic SMA (<5120 mm^2)

Experimental group

Description:

Adjusted paclitaxel infusion time during only one dose; standard paclitaxel infusion time for all other doses.

Treatment:

Drug: Paclitaxel

Drug: Paclitaxel