NCT01326767

Central European Society for Anticancer Research (CESAR) Study of Paclitaxel Therapeutic Drug Monitoring

An Open-Label, Randomized, Parallel Group Study of Patients Treated With Paclitaxel With Standard Dosing Versus Pharmacokinetic Guided Dose Adjustment in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Central European Society for Anticancer Drug Research · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will be performed on grade IIIb and grade IV Non Small Cell Lung Cancer (NSCLC) chemotherapy naive patients with good performance status. In course of this study, patients will be treated with Paclitaxel in combination with either Cisplatin or Carboplatin in a maximum of six therapy cycles. The goal of this study is to determine, if a pharmakokinetic driven dose adaptation of paclitaxel leads to a reduction of of grade 4 neutropenia, compared to conventional Paclitaxel dosing, without affecting progression free survival and overall survival. This study includes a biomarker analysis and an optional genetic substudy.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Paclitaxel dosing according to SmPC	Paclitaxel i.V. Up to 6 cycles Dosing according to SmPC
DRUG	Individualized pharmacokinetically driven paclitaxel dosing	Paclitaxel i.V. Up to 6 cycles Dosing based on patient age, gender, severity of neutropenia and Paclitaxel plasma concentration

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-03-31
• Last updated: 2016-01-27

Locations

11 sites across 2 countries: Germany, Switzerland