NCT01621425|Completed
Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity
LEANDOC
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LEANDOC
Sponsor study identifier
observational
25
1 country
2
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)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. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 25, 2012
Actual (reported)June 2012
Date type not reportedThis date has not been verified as actual or estimated.
June 18, 2012
Actual (reported)May 2015
Actual (reported)May 2015
Actual (reported)anthropometric parameters related to exposure
To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC) for both males and females
within one week prior to first docetaxel dose
relation between docetaxel toxicity and dose/LBM
1 cycle (21 days)
determine the best method to measure lean body mass
within one week prior to first docetaxel dose
Female subject diagnosed with breast carcinoma and will receive docetaxel treatment according to standard hospital protocol
male subject diagnosed with metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol
Lean Body mass (DEXA scan and Bioelectrical Impedance Assessments) within one week prior to the first docetaxel dose
Total Body weight (TBW) (scale) within one week prior to the first docetaxel dose
20 female subjects who are diagnosed with breast and 20 male subjects with metas-tatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol (TAC or PRODOC regimens)
Deventer Hospital
Deventer, Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Blood samples for docetaxel concentration measurement (n=4)
Rien Hoge, PharmD
Deventer Ziekenhuis
Frank Jansman, PharmD, PhD
Deventer Ziekenhuis
25 participants (actual enrollment reported by the registry).
First Submitted
May 25, 2012
First Posted
June 18, 2012
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
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
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Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)Last Updated
August 13, 2015
Record last verified: 2015-08
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Source: ClinicalTrials.gov.
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