No registrations found.
ID
Source
Brief title
Health condition
pharmacokinetics; caelyx; cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess age-related differences in PEG DOXO area under the curve (AUC) in elderly as compared to younger female cancer patients.
Secondary outcome
1. To assess age-related differences in PEG DOXO clearance (Cl) and terminal half life (T½z) in elderly as compared to younger female cancer patients;
2. To assess intra-patient variation of the AUC, Cl and T½ in both cohorts;
3. To assess age-related differences in toxicities associated with PEG DOXO in elderly as compared to younger female cancer patients;
4. To relate the toxicities associated with PEG DOXO to the PK data in both cohorts.
Background summary
Pharmacokinetic evaluation of the impact of age on the pharmacokinetics of caelyx.
Study objective
Pharmacokinetics of caelyx may be altered in the elderly due to physiological changes.
Study design
N/A
Intervention
Pharmacokinetic sampling.
A.P. Hamberg
Sint Franciscus Gasthuis
Kleiweg 500
Rotterdam 3045 PM
The Netherlands
p.hamberg@sfg.nl
A.P. Hamberg
Sint Franciscus Gasthuis
Kleiweg 500
Rotterdam 3045 PM
The Netherlands
p.hamberg@sfg.nl
Inclusion criteria
1. Woman;
2. Solid tumour;
3. Under treatment with calyx;
4. Age 18 years or older.
Exclusion criteria
1. Evidence of metastases in the central nervous system, unless previously treated and being asymptomatic/controlled for at least 3 months;
2. History of cardiac disease, with NYHA Class II or greater, or clinical evidence of congestive heart failure or myocardial infarction within less than six months;
3. Abuse of drugs, alcohol, pharmaceuticals, competing with adequate compliance in this study.
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 | NL2540 |
| NTR-old | NTR2658 |
| Other | MEC Erasmus MC : 08-138 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |