Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity (LEANDOC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Radboud University
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01621425
First received: May 25, 2012
Last updated: April 29, 2014
Last verified: April 2014

May 25, 2012
April 29, 2014
June 2012
July 2014   (final data collection date for primary outcome measure)
anthropometric parameters related to exposure [ Time Frame: within one week prior to first docetaxel dose ] [ Designated as safety issue: No ]
To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC) for both males and females
Same as current
Complete list of historical versions of study NCT01621425 on ClinicalTrials.gov Archive Site
  • relation between docetaxel toxicity and dose/LBM [ Time Frame: 1 cycle (21 days) ] [ Designated as safety issue: Yes ]
    can docetaxel toxicity be related to dose/LBM? docetaxel toxicity is defined as: number of rates of grade 3/4 toxicity, dose delay, dose reduction, treatment termination and combinations of all four as Dose-Limiting Toxicity (DLT)
  • determine the best method to measure lean body mass [ Time Frame: within one week prior to first docetaxel dose ] [ Designated as safety issue: No ]
    To determine which methods to measure LBM: Bioelectrical Impedance As-sessments (BIA) or formula estimates are accurate enough for dosing calculations to be used for dosing docetaxel. These methods will be compared to the LBM derived from the DEXA scan as the general accepted, accurate and validated method for determining LBM.
Same as current
Not Provided
Not Provided
 
Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity
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.

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood samples for docetaxel concentration measurement (n=4)

Non-Probability Sample

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)

  • Breast Cancer
  • Metastatic Castration-resistant Prostate Carcinoma
  • Other: Lean body mass
    Lean Body mass (DEXA scan and Bioelectrical Impedance Assessments) within one week prior to the first docetaxel dose
  • Other: Total body weight
    Total Body weight (TBW) (scale) within one week prior to the first docetaxel dose
  • Other: 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
  • TAC regimen
    Female subject diagnosed with breast carcinoma and will receive docetaxel treatment according to standard hospital protocol
    Interventions:
    • Other: Lean body mass
    • Other: Total body weight
    • Other: bloodsampling
  • PRODOC regimen
    male subject diagnosed with metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol
    Interventions:
    • Other: Lean body mass
    • Other: Total body weight
    • Other: bloodsampling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: David Burger, Prof +31 24 3616405 d.burger@akf.umcn.nl
Contact: Angela Colbers, MSc +31 24 3616405 a.colbers@akf.umcn.nl
Netherlands
 
NCT01621425
UMCN-AKF 11.01
No
Radboud University
Radboud University
Not Provided
Principal Investigator: Rien Hoge, PharmD Deventer Ziekenhuis
Study Chair: Frank Jansman, PharmD, PhD Deventer Ziekenhuis
Radboud University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP