The relationship between the conversion and excretion of docetaxel and paclitaxel and variation in DNA.
Recruiting
- Conditions
- cancer, docetaxel, paclitaxel, pharmacokinetics, pharmacodynamics, pharmacogenetics
- Registration Number
- NL-OMON25570
- Lead Sponsor
- sponsor: Erasmus Medical Center, Daniel den Hoed Cancer Center 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
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 700
Inclusion Criteria
1. Age >18 years;
2. Treated with docetaxel or paclitaxel;
Exclusion Criteria
Use of known CYP3A4 inducers/inhibitors.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic outcomes: AUC and Clearance;<br /><br>Measured by: NONMEM population analysis.<br>
- Secondary Outcome Measures
Name Time Method Pharmacodynamic outcomes: Toxicity (grade of neutropenia, leucopenia, thrombocytopenia, anemia, neutropenic fever, neurotoxicity);<br /><br>Measured by: Clinicians assessment during treatment, grading according to CTC criteria.<br>