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

Use of limited sampling strategy to evaluate the relationship between pharmacokinetics and farmacogenetics of the anticancer drugs Docetaxel (Taxotere) and Paclitaxel (Taxol).

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25570
Enrollment
700
Registered
2010-04-20
Start date
2004-05-12
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer, docetaxel, paclitaxel, pharmacokinetics, pharmacodynamics, pharmacogenetics

Interventions

None listed

Sponsors

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
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Use of known CYP3A4 inducers/inhibitors.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic outcomes: AUC and Clearance; Measured by: NONMEM population analysis.—

Secondary

MeasureTime frame
Pharmacodynamic outcomes: Toxicity (grade of neutropenia, leucopenia, thrombocytopenia, anemia, neutropenic fever, neurotoxicity); Measured by: Clinicians assessment during treatment, grading according to CTC criteria.—

Contacts

Public ContactAnne-Joy M. Graan, de

Groene Hilledijk 301

a.degraan@erasmusmc.nl+31 (0)10 7041338

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)