An observational study to determine the pharmacokinetics of pemetrexed with and without hyperhydration during cisplatin administration (HYDRA).
Completed
- Conditions
- lung cancerNSCLC10038666
- Registration Number
- NL-OMON44619
- Lead Sponsor
- Jeroen Bosch Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
1. *18 years old
2. Planned for treatment with cisplatin/pemetrexed combination therapy followed by pemetrexed maintenance therapy as a part of routine care.
3. Creatinine clearance * 45ml/min
4. Subject is able and willing to sign the Informed Consent Form.
Exclusion Criteria
1. Patients that suffer from conditions that affect hemostasis in a way that blood drawing is complicated (to be assessed by physician) are excluded.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The aim is to assess if there is a relevant and significant difference in<br /><br>pemetrexed exposure (clearance, Cl) as a result of hyperhydration during<br /><br>treatment with pemetrexed. A relevant clinical effect is defined a 25%<br /><br>difference in clearance. </p><br>
- Secondary Outcome Measures
Name Time Method <p>As a secondary study parameter, the comparative performance of different renal<br /><br>function algorithms for the prediction of clearance is assessed. </p><br>