To determine if there is a difference in the pharmacokinetics of low-dose cisplatin with and without prehydration.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is a difference in pharmacokinetics (Cmax and AUC) of
cisplatin.
Secondary outcome
The secundary study parameter is a difference in platinum-DNA adducts in white
blood cells and a difference in urinal excretion of cisplatin.
Background summary
Low-dose cisplatin can cause nephrotoxicity, which can be reduced by
prehydration. In 2011, the clinical treatment protocol in AVL was altered from
optional prehydration in patients with manifest nephrotoxicity, to standard
prehydration in all patients. However, pre-clinical data recently demonstrated
that prehydration can lower the cisplatin concentration in the tumor. This
effect now needs to be evaluated in humans. Since measuring tumoral cisplatin
concentrations is difficult in patients, this study will focus on the
pharmacokinetics of cisplatin with and without prehydration.
Study objective
To determine if there is a difference in the pharmacokinetics of low-dose
cisplatin with and without prehydration.
Study design
A 2x2 cross-over design. Patients in group 1 will receive no prehydration on
day 1 and prehydration on day 2. Patients in group 2 will receive prehydration
on day 1 but no prehydration on day 2. The pharmacokinetics of cisplatin will
be measured in blood samples and the excretion of cisplatin will be measured in
urine.
Intervention
Patients in group 1 will receive no prehydration on day 1 and prehydration on
day 2. Patients in group 2 will receive prehydration on day 1 but no
prehydration on day 2. On all other days (up to 25), pre-hydration will be
given according to standard clinical protocol.
Study burden and risks
Burden: Patients will need an extra intravenous catheter twice, through which
blood samples will be taken 9x in one day. Patients will need to stay in the
hospital for 7 hours on two days instead of the usual 2 hours.
Risks: Removing the prehydration can lead to nephrotoxicity. To keep this risk
as low as possible, only patients receiving daily low-dose cisplatin (6 mg/m2)
are included and only 1 of the 24 or 25 doses is given without prehydration.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
- Scheduled for concurrent low-dose cisplatin and radiotherapy
- > 18 years old
- GFR > 60
- able to provide informed consent
Exclusion criteria
- Prior treatment with platinum compounds
- Poor kidney function (GFR <60)
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2015-002026-39-NL |
| CCMO | NL53446.031.15 |