NCT05183126

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Breast Cancer
• Metastatic Gastric Cancer
• Esophageal Cancer

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-03-28
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2022-01-10
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study