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Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity

NCT01621425 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2015-08-13

No results posted yet for this study

Summary

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.

Conditions

  • Breast Cancer
  • Metastatic Castration-resistant Prostate Carcinoma

Interventions

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

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Rien Hoge, PharmD · Deventer Ziekenhuis

  • Frank Jansman, PharmD, PhD · Deventer Ziekenhuis

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01621425 on ClinicalTrials.gov