No registrations found.
ID
Source
Brief title
Health condition
cancer, docetaxel, paclitaxel, pharmacokinetics, pharmacodynamics, pharmacogenetics
Sponsors and support
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
Intervention
Outcome measures
Primary outcome
Pharmacokinetic outcomes: AUC and Clearance;
Measured by: NONMEM population analysis.
Secondary outcome
Pharmacodynamic outcomes: Toxicity (grade of neutropenia, leucopenia, thrombocytopenia, anemia, neutropenic fever, neurotoxicity);
Measured by: Clinicians assessment during treatment, grading according to CTC criteria.
Background summary
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.
Study objective
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.
Study design
1. DNA sampling;
2. At 4 different timepoints blood sampling for PK analysis.
Intervention
N/A
Anne-Joy M. Graan, de
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041338
a.degraan@erasmusmc.nl
Anne-Joy M. Graan, de
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041338
a.degraan@erasmusmc.nl
Inclusion criteria
1. Age >18 years;
2. Treated with docetaxel or paclitaxel;
3. Written informed consent;
4. Written informed consent regarding single bloodsample for DNA analysis.
Exclusion criteria
Use of known CYP3A4 inducers/inhibitors.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2187 |
| NTR-old | NTR2311 |
| Other | Medical Ethical Approval Board Erasmus Medical Center : 03-264 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |