An observational study to determine the pharmacokinetics of pemetrexed with and without hyperhydration during cisplatin administration (HYDRA).

An observational study to determine the pharmacokinetics of pemetrexed with and without hyperhydration during cisplatin administration (HYDRA). - Influence of hyperhydration on pemetrexed pharmacokinetics (HYDRA)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44619

Enrollment

Registered

2017-12-20

Start date

2018-04-11

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer NSCLC

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The aim is to assess if there is a relevant and significant difference in pemetrexed exposure (clearance, Cl) as a result of hyperhydration during treatment with pemetrexed. A relevant clinical effect is defined a 25% difference in clearance.	—

Secondary

Measure	Time frame
As a secondary study parameter, the comparative performance of different renal function algorithms for the prediction of clearance is assessed.	—

Countries

Netherlands

Outcome results