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

NCT01326767 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2016-01-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Saladax Biomedical, Inc.

    collaborator INDUSTRY

  • Cantonal Hospital of St. Gallen

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    collaborator OTHER

  • Assign Data Management and Biostatistics GmbH

    collaborator OTHER

  • Wake Forest University

    collaborator OTHER

  • University Hospital, Essen

    collaborator OTHER

  • Central European Society for Anticancer Drug Research

    lead OTHER

Principal Investigators

  • Markus Joerger, MD PhD · Central European Society for Anticancer Drug Research

  • Ulrich Jaehde, PhD · Central European Society for Anticancer Drug Research

  • Frank Mayer, MD · Eberhard-Karls-Universität Tübingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01326767 on ClinicalTrials.gov