Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity
18 Years
N/A
Both
Breast Cancer, Metastatic Castration-resistant Prostate Carcinoma
Trial Information
Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity
Docetaxel is used as a first line anti-cancer drug in the treatment of several cancers,
mainly breast- and metastatic castration-resistant prostate carcinoma.
Anti-cancer drugs are being dosed based on patients estimated Body Surface Area in order to
equalize total drug exposure. Nevertheless, docetaxel treatment is characterized by highly
interindividual pharmacokinetic variation leading to toxicity and under-treatment.
For most anti-cancer drugs, including docetaxel, other anthropometric parameters, such as
Lean Body Mass (LBM), have been suggested to be superior to Body Surface Are (BSA) as a
determinant for dosing but this has not been implemented in clinical practice.
The investigators will determine which anthropometric parameters, LBM, total body weight
(TBW) or BSA correlate best to docetaxel exposure (AUC) for both males and females.
The investigators will determine if occurrence of docetaxel toxicity can be related to
dose/LBM.
The investigators will determine which methods to measure LBM: DEXA, Bioelectrical Impedance
Assessments (BIA) or formula estimates are accurate enough for dosing calculations to be
used for dosing docetaxel.
Inclusion Criteria:
- Subject is at least 18
- Subject is able and willing to sign the Informed Consent Form prior to screening
evaluations
- Female subject diagnosed with breast carcinoma and will receive docetaxel treatment
according to standard hospital protocol (TAC regimen) or male subject diagnosed with
metastatic castration-resistant prostate carcinoma and will receive docetaxel
treatment according to standard hospital protocol (PRODOC regimen)
- Subject has a live expectancy of 12 weeks or greater
- Absolute neutrophile count (ANC) > 1.5 x 10E9/L
- Platelet count > 100 x 10E9/L
- Serum creatinine ≤ 2 x ULN
- Total bilirubin level < 1.5 x ULN
Exclusion Criteria:
- Docetaxel treatment within the last year
- Moderate or severe liver impairment; [ALAT and/or ASAT ≥ 1.5 ULN] and [AF ≥ 2.5 ULN]
- Current therapy with any drug, dietary supplements, or other compounds, or have been
used in the last 2 weeks prior to the first docetaxel administration, known to
inhibit or induce CYP3A4.
- Inability to understand the nature and extent of the study and the procedures
required
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
anthropometric parameters related to exposure
Outcome Description:
To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC) for both males and females
Outcome Time Frame:
within one week prior to first docetaxel dose
Safety Issue:
No
Principal Investigator
Rien Hoge, PharmD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Deventer Ziekenhuis
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
UMCN-AKF 11.01
NCT ID:
NCT01621425
Start Date:
June 2012
Completion Date:
May 2013
Related Keywords:
- Breast Cancer
- Metastatic Castration-resistant Prostate Carcinoma
- breast cancer
- prostate carcinoma
- docetaxel
- lean body mass
- Body Surface Area
- body weight
- dexascan
- Breast Neoplasms
- Carcinoma
- Prostatic Neoplasms
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