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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01326767
Recruitment Status : Completed
First Posted : March 31, 2011
Last Update Posted : January 27, 2016
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Paclitaxel dosing according to SmPC Drug: Individualized pharmacokinetically driven paclitaxel dosing Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : March 2011
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Paclitaxel dosing according to SmPC Drug: Paclitaxel dosing according to SmPC
Paclitaxel i.V. Up to 6 cycles Dosing according to SmPC
Experimental: Individualized pharmacokinetically driven paclitaxel dosing
In the first treatment cycle, the Paclitaxel dose is adapted depending on the age and the gender of the patient. In the treatment cycles 2-6 the Paclitaxel dose is adapted based on individual PK data and toxicities.
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

Outcome Measures

Primary Outcome Measures :
  1. Grad 4 Neutropenia [ Time Frame: up to 6 weeks on treatment ]
    The rate of grade 4 Neutropenia during the second treatment cycle between the conventional Paclitaxel dosing arm and pharmacokinetically driven Paclitaxel dosing arm is compared. At the same time progression free survival and overall survival must not be affected.

Secondary Outcome Measures :
  1. Objective tumor response according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST v1.1) [ Time Frame: 24 months ]
  2. Progression free survival [ Time Frame: 24 month ]
  3. Overall survival [ Time Frame: 24 month ]
  4. Overall neutropenia [ Time Frame: 24 month ]
    Overall neutropenia ( i.e. during total chemotherapy duration) assessed from clinical hematology data and by model-based estimations of individual neutrophil curves

  5. Hematological / non-hematological toxicites [ Time Frame: 24 months ]
    Hematological (leucocytopenia, anemia, thrombocytopenia) and non-hematological toxicities (e.g. neurological, musculosceletal and gastrointestinal adverse events)

  6. Cumulative dose and dose intensity of paclitaxel and platinum drug [ Time Frame: 24 months ]
  7. Incidence of changes from cisplatin to carboplatin and reasons thereof [ Time Frame: 24 months ]
  8. Overall rate of febrile neutropenia and hospitalization due to chemotherapy-associated adverse events [ Time Frame: 24 months ]
  9. Health economic analysis using QoL Questionnaires [ Time Frame: 24 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Capable of understanding the protocol requirements and risks, and providing written informed consent.
  • Patients with histologically confirmed NSCLC (stage IIIB-IV).
  • Patients considered for first-line palliative chemotherapy with paclitaxel in combination with either cisplatin or carboplatin. Patients having received prior adjuvant non taxane-containing adjuvant chemotherapy are eligible.
  • At least one bidimensionally measurable lesion according to RECIST 1.1.
  • ECOG Performance Status (ECOG-PS) status ≤ 2.
  • Female or male patients of 18 to 75 years of age at randomization
  • Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum pregnancy test within 1 week prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods (condom).
  • An absolute neutrophil count >1,500 cells/ mm3 (= 1.5 G/l).
  • Platelet count > 100,000/mm3.
  • Total bilirubin ≤ 2 x upper limit of normal.
  • AST and ALT ≤ 2.5 x upper limit of normal, or ≤ 5 x upper limit of normal in case of liver metastases.
  • Creatinine clearance (according to the Cockcroft-Gault formula) ≥30ml/min. For patients planned to receive Cisplatin: Creatinine clearance ≥60ml/min.
  • Patients suffering from asymptomatic brain metastases can be enrolled in case corticosteroid therapy is not indicated. Prior irradiation must be completed at least 4 weeks prior to first cycle of treatment.

Exclusion Criteria:

  • Serious concomitant systemic disorders (e.g., active infection, severe heart disease, uncontrolled hypertension or diabetes mellitus) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
  • A history of hypersensitivity reactions to drugs formulated in polyoxyethylated castor oil.
  • Having received prior treatment with paclitaxel or cisplatin or carboplatin (other drugs/drug combinations are allowed).
  • Concomitant treatment with any targeted drug (licensed or experimental) like bevacizumab or cetuximab.
  • Any condition / concomitant disease not allowing chemotherapy with paclitaxel, the platinum compound (carboplatin or cisplatin) or required premedication for the treatment regimen.
  • Pregnant/nursing women.
  • Individuals known to be seropositive for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen or syphilis.
  • Treatment with cytotoxic or biologic agents or any experimental drug within the 4 weeks prior to beginning treatment on this study.
  • Secondary malignancy within the last five years, with the exception of adequately treated carcinoma-in-situ of the uterine cervix, basal-cell carcinoma of the skin and pTa or pTis urothelial cancer.
  • Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.
  • Preexisting neuropathy > grade I NCI-CTC.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326767

CESAR Study Center
Bochum, Germany
CESAR study center
Bonn, Germany
CESAR Study Center
Essen, Germany
CESAR study center
Gerlingen, Germany
CESAR study center
Großhansdorf, Germany
CESAR Study Center
Halle an der Saale, Germany
CESAR Study Center
Leer, Germany
CESAR Study Center
Löwenstein, Germany
CESAR Study Center
Munich, Germany
CESAR Study Center
Tübingen, Germany
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Central European Society for Anticancer Drug Research
Saladax Biomedical, Inc.
Cantonal Hospital of St. Gallen
University Hospital, Basel, Switzerland
Assign Data Management and Biostatistics GmbH
Wake Forest University
University Hospital, Essen
Study Chair: Markus Joerger, MD PhD Central European Society for Anticancer Drug Research
Study Director: Ulrich Jaehde, PhD Central European Society for Anticancer Drug Research
Principal Investigator: Frank Mayer, MD Eberhard-Karls-Universität Tübingen
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Central European Society for Anticancer Drug Research
ClinicalTrials.gov Identifier: NCT01326767     History of Changes
Other Study ID Numbers: C-III-002
2010-023688-16 ( EudraCT Number )
First Posted: March 31, 2011    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action