No registrations found.
ID
Source
Brief title
Health condition
English:
Breast cancer, prostate cancer, non-small cell lung cancer (NSCLC).
Dutch:
Borstkanker, prostaatkanker, niet-kleincellig longcarcinoom.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacokinetics of a microdose
Secondary outcome
The relationship of the pharmacokinetics with therapeutic docetaxel dose pharmacokinetics
Background summary
This study will be a single center cross-sectional prospective pharmacokinetic study. Patients with breast-, prostate, non-small cell lung carcinoma (NSCLC), who are already eligible for therapeutic treatment with docetaxel as a part of routine care will receive a bolus microdose (1000ìg) of intravenous docetaxel 1 to 7 days prior to the therapeutic docetaxel administration. Blood samples will be taken. The aim is to establish the relationship between a microdoce and therapeutic dose docetaxel pharmacokinetic and to develop a limiting sampling model for prediction of therapeutic dose docetaxel pharmacokinetics from a microdoce docetaxel.
Study objective
Docetaxel has a narrow therapeutic index and shows a wide interpatient variability in clearance and toxicity. There is a need for a tool to predict efficacy of docetaxel in individual patients.
We hypothesize that the pharmacokinetics of a microdose and therapeutic dose of docetaxel can be reliably interpolated.
Study design
- Pharmacokinetics after 0.25, 1, 2, 4, 6 and 8 hours after end of infusion of the microdose and the therapeutic dose of doxetaxel.
Intervention
- Microdose Docetaxel (1000 ìg)
Patients who are already eligible for therapeutic treatment with docetaxel as a part of routine care will receive a bolus microdose (1000ìg) of intravenous docetaxel 1 to 7 days prior to the therapeutic docetaxel administration.
Jessica Notohardjo
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+3120 4444881
j.notohardjo@vumc.nl
Jessica Notohardjo
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+3120 4444881
j.notohardjo@vumc.nl
Inclusion criteria
Patients with breast-, prostate and non-small cell lung cancer, who are planned for routine treatment with docetaxel
Exclusion criteria
- Absence of informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7199 |
| NTR-old | NTR7398 |
| CCMO | NL59339.100.16 |
| OMON | NL-OMON49402 |