Tumor
Conditions
Interventions
Trade Name: Cisplatin
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Sodium Chloride 0.9 %
Pharmaceutical Form: Solution for infusion
Sponsors
NKI-AVL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Scheduled for concurrent chemoradiotherapy with daily low-dose (6 mg/m2) cisplatin - GFR > 60 - > 18 years old - able to provide informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - Prior therapy with platinum based drugs. - Poor kidney function (GFR < 60)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if there is a difference in the pharmacokinetics of lowdose cisplatin with and without prehydration.;Secondary Objective: To determine if there is a difference in platinum-DNA adducts in white blood cells with and without prehydration.;Primary end point(s): The primary endpoint is a difference in pharmacokinetics (Cmax and AUC) of cisplatin.;Timepoint(s) of evaluation of this end point: Pharmacokinetics will be measured and compared on day 1 and day 2 of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint is a difference in platinum-DNA adducts in white blood cells.;Timepoint(s) of evaluation of this end point: Platinum-DNA adducts will be measured and compared on day 1 of treatment. | — |
Countries
Netherlands
Contacts
Public ContactPrinciple Investigator
NKI-AVL
Outcome results
None listed