The inter-individual pharmacokinetic and pharmacodynamic variability for the anticancer drugs docetaxel and paclitaxel is due to patient characteristics, genetic variability and life style factors.
ID
Bron
Verkorte titel
Aandoening
cancer, docetaxel, paclitaxel, pharmacokinetics, pharmacodynamics, pharmacogenetics
Ondersteuning
address: P.O. Box 5201
postal code: 3008 AE
city: Rotterdam
country: The Netherlands
phone: +31 (0)10 4391568
fax: +31 (0)10 4391028
email: hdc@erasmusmc.nl
Postbus 75508
1070 AM Amsterdam
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Pharmacokinetic outcomes: AUC and Clearance;<br>
Measured by: NONMEM population analysis.
Achtergrond van het onderzoek
The purpose of this study is to establish pharmacogenetic markers for therapy with the taxanes paclitaxel and docetaxel. At present, toxicity is still a major clinical problem, and interindividual variability in pharmacokinetics and pharmacodynamics is extensive and largely unexplained. Toxicity and outcome are often related to pharmacokinetics. At present, there is no individualisation of taxane treatment other than dose adjustment for body suface area. Genetic variability is one of the most promising biomarkers that may be used to predict taxane pharmacokinetics and pharmacodynamics. This could minimize side-effects and maximize therapeutic efficacy in taxane treated patients.
Doel van het onderzoek
The inter-individual pharmacokinetic and pharmacodynamic variability for the anticancer drugs docetaxel and paclitaxel is due to patient characteristics, genetic variability and life style factors.
Onderzoeksopzet
1. DNA sampling;
2. At 4 different timepoints blood sampling for PK analysis.
Onderzoeksproduct en/of interventie
N/A
Publiek
Anne-Joy M. Graan, de
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041338
a.degraan@erasmusmc.nl
Wetenschappelijk
Anne-Joy M. Graan, de
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041338
a.degraan@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age >18 years;
2. Treated with docetaxel or paclitaxel;
3. Written informed consent;
4. Written informed consent regarding single bloodsample for DNA analysis.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Use of known CYP3A4 inducers/inhibitors.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2187 |
| NTR-old | NTR2311 |
| Ander register | Medical Ethical Approval Board Erasmus Medical Center : 03-264 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |