Observational study to evaluate pharmacokinetics and pharmacodynamics of docetaxel, paclitaxel, doxorubicin, gemcitabine, vinorelbine, and capecitabine in elderly patients.

Completed

• Conditions: cancer malignancies; 10027655

• Registration Number: NL-OMON47924
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2018-09-23
• Study Completion: 2023-09-07
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 337

Inclusion Criteria

1. Planned to receive docetaxel, paclitaxel, doxorubicin, gemcitabine, vinorelbine, or capecitabine as regular treatment for cancer; 2. Age >= 70 years; 3. Able and willing to give written informed consent prior to participation in the trial; 4. Able and willing to undergo blood sampling for pharmacokinetics.

Exclusion Criteria

No exclusion criteria are applicable.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic parameters Serum concentrations of each included agent (absolute values and relative to data retrieved from adult patients < 70 years)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmacodynamic parameters (serious) adverse events effectiveness (PFS, RR)</p><br>