Phase IV Single-arm Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Maximum concentration (Cmax) of paclitaxel plasma
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
- •≥ 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
排除标准
- •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
研究组 & 干预措施
Normal SMA (>7310 mm^2)
Standard paclitaxel infusion time.
干预措施: Paclitaxel (Drug)
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.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Maximum concentration (Cmax) of paclitaxel plasma
时间窗: 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.
次要结局
- Two- to three-hour Cmax vs. one-hour Cmax in low SMA patients(Up to week 12)
- One-hour Cmax in normal SMA patients vs. one-hour Cmax in low SMA patients(Up to week 12)