Central European Society for Anticancer Research (CESAR) Study of Paclitaxel Therapeutic Drug Monitoring
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Central European Society for Anticancer Drug Research
Collaborators:
Assign Data Management and Biostatistics GmbH Cantonal Hospital of St. Gallen Saladax Biomedical, Inc. University Hospital, Basel, Switzerland University Hospital, Essen Wake Forest University Wake Forest University Health Sciences need to be deleted