Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity
NCT ID: NCT01621425
Last Updated: 2015-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
25 participants
OBSERVATIONAL
2012-06-30
2015-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
NCT01537029
Docetaxel in Treating Older Patients With Metastatic Breast, Lung, or Prostate Cancer
NCT00059943
Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer
NCT05183126
Capecitabine Pharmacokinetics(PK)-Actual Versus Ideal Body Weight
NCT01828554
Effect of Cabozantinib S-Malate or Lenvatinib Mesylate on Weight and Body Composition in Patients With Metastatic Endocrine Cancer
NCT02592356
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TAC regimen
Female subject diagnosed with breast carcinoma and will receive docetaxel treatment according to standard hospital protocol
Lean body mass
Lean Body mass (DEXA scan and Bioelectrical Impedance Assessments) within one week prior to the first docetaxel dose
Total body weight
Total Body weight (TBW) (scale) within one week prior to the first docetaxel dose
bloodsampling
Blood samples will be taken during the first docetaxel administration of the first cycle, just before docetaxel infusion (t=0 min.), 30 min after start of infusion (t=30 min.), just prior to end of infusion (t=55 min.) and between 3 to 6 hours post start infusion following a limited sampling model
PRODOC regimen
male subject diagnosed with metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol
Lean body mass
Lean Body mass (DEXA scan and Bioelectrical Impedance Assessments) within one week prior to the first docetaxel dose
Total body weight
Total Body weight (TBW) (scale) within one week prior to the first docetaxel dose
bloodsampling
Blood samples will be taken during the first docetaxel administration of the first cycle, just before docetaxel infusion (t=0 min.), 30 min after start of infusion (t=30 min.), just prior to end of infusion (t=55 min.) and between 3 to 6 hours post start infusion following a limited sampling model
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lean body mass
Lean Body mass (DEXA scan and Bioelectrical Impedance Assessments) within one week prior to the first docetaxel dose
Total body weight
Total Body weight (TBW) (scale) within one week prior to the first docetaxel dose
bloodsampling
Blood samples will be taken during the first docetaxel administration of the first cycle, just before docetaxel infusion (t=0 min.), 30 min after start of infusion (t=30 min.), just prior to end of infusion (t=55 min.) and between 3 to 6 hours post start infusion following a limited sampling model
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Radboud University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rien Hoge, PharmD
Role: PRINCIPAL_INVESTIGATOR
Deventer Ziekenhuis
Frank Jansman, PharmD, PhD
Role: STUDY_CHAIR
Deventer Ziekenhuis
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Deventer Hospital
Deventer, , Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UMCN-AKF 11.01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.