pharmacokinetics
Conditions
Interventions
Pharmacokinetic sampling.
Sponsors
Erasmus University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Woman; 2. Solid tumour; 3. Under treatment with calyx; 4. Age 18 years or older.
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess age-related differences in PEG DOXO area under the curve (AUC) in elderly as compared to younger female cancer patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactA.P. Hamberg
PO Box 5201
Outcome results
None listed