Prehydration and low-dose cisplati

• Conditions: Tumor; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002026-39-NL
• Lead Sponsor: KI-AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-08
• Last Update Posted: 6 October 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

- Prior therapy with platinum based drugs.
- Poor kidney function (GFR < 60)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine if there is a difference in the pharmacokinetics of lowdose<br>cisplatin with and without prehydration.;Secondary Objective: To determine if there is a difference in platinum-DNA adducts in white<br>blood cells with and without prehydration.;Primary end point(s): The primary endpoint is a difference in pharmacokinetics (Cmax and<br>AUC) of cisplatin.;Timepoint(s) of evaluation of this end point: Pharmacokinetics will be measured and compared on day 1 and day 2 of<br>treatment.

Secondary Outcome Measures

Name	Time	Method
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<br>treatment.