search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


The relationship between the conversion and excretion of docetaxel and paclitaxel and variation in DNA.


- candidate number7951
- NTR NumberNTR2311
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-apr-2010
- Secondary IDs03-264 Medical Ethical Approval Board Erasmus Medical Center
- Public TitleThe relationship between the conversion and excretion of docetaxel and paclitaxel and variation in DNA.
- Scientific TitleUse of limited sampling strategy to evaluate the relationship between pharmacokinetics and farmacogenetics of the anticancer drugs Docetaxel (Taxotere) and Paclitaxel (Taxol).
- ACRONYMN/A
- hypothesisThe inter-individual pharmacokinetic and pharmacodynamic variability for the anticancer drugs docetaxel and paclitaxel is due to patient characteristics, genetic variability and life style factors.
- Healt Condition(s) or Problem(s) studiedCancer, Paclitaxel , Docetaxel, Pharmacokinetics, Pharmacodynamics, Pharmacogenetics
- Inclusion criteria1. Age >18 years;
2. Treated with docetaxel or paclitaxel;
3. Written informed consent;
4. Written informed consent regarding single bloodsample for DNA analysis.
- Exclusion criteriaUse of known CYP3A4 inducers/inhibitors.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 12-mei-2004
- planned closingdate1-jan-2014
- Target number of participants700
- InterventionsN/A
- Primary outcomePharmacokinetic outcomes: AUC and Clearance;
Measured by: NONMEM population analysis.
- Secondary outcomePharmacodynamic outcomes: Toxicity (grade of neutropenia, leucopenia, thrombocytopenia, anemia, neutropenic fever, neurotoxicity);
Measured by: Clinicians assessment during treatment, grading according to CTC criteria.
- Timepoints1. DNA sampling;
2. At 4 different timepoints blood sampling for PK analysis.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. MSc Anne-Joy M. Graan, de
- CONTACT for SCIENTIFIC QUERIESMD PhD Ron H.J. Mathijssen
- Sponsor/Initiator Erasmus Medical Center, Daniel den Hoed Cancer Center
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD20-apr-2010 - 16-mei-2010


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl