Status:
RECRUITING
Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Breast Cancer
Metastatic Gastric Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 pa...
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-medic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05183126
Start Date
March 28 2022
End Date
December 1 2025
Last Update
April 2 2025
Active Locations (1)
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1
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109