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Carcinoma, Non-Small-Cell LungPhase 3CEPAC-TDMNCT01326767

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

A Phase 3 study testing Paclitaxel dosing according to SmPC and Individualized pharmacokinetically driven paclitaxel dosing in people with Carcinoma, Non-Small-Cell Lung, run by Central European Society for Anticancer Drug Research at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Paclitaxel dosing according to SmPC and Individualized pharmacokinetically driven paclitaxel dosing
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
366 participants
Where
11 sitesin 2 countries
Study dates
Mar 2011to Dec 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

Germany10 sites

  • CESAR Study Center

    Bochum

  • CESAR study center

    Bonn

  • CESAR Study Center

    Essen

  • CESAR study center

    Gerlingen

  • CESAR study center

    Großhansdorf

  • CESAR Study Center

    Halle

  • CESAR Study Center

    Leer

  • CESAR Study Center

    Löwenstein

  • CESAR Study Center

    Munich

  • CESAR Study Center

    Tübingen

Other trials in Germany

Switzerland1 site

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

About this study

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)

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.

Being tested
Paclitaxel dosing according to SmPC, Individualized pharmacokinetically driven paclitaxel dosing
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paclitaxel dosing according to SmPCDrug

    Paclitaxel i.V. Up to 6 cycles Dosing according to SmPC

  • Individualized pharmacokinetically driven paclitaxel dosingDrug

    Paclitaxel i.V. Up to 6 cycles Dosing based on patient age, gender, severity of neutropenia and Paclitaxel plasma concentration

Study groups in NCT01326767
Study groupRoleWhat they receive
Paclitaxel dosing according to SmPCActive comparatorNot described
Receives: Drug: Paclitaxel dosing according to SmPC
Individualized pharmacokinetically driven paclitaxel dosingExperimentalIn 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.
Receives: Drug: Individualized pharmacokinetically driven paclitaxel dosing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Grad 4 Neutropenia

    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.

    Measured: up to 6 weeks on treatment

Secondary outcomes (9)

  1. Objective tumor response according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST v1.1)

    Measured: 24 months

  2. Progression free survival

    Measured: 24 month

  3. Overall survival

    Measured: 24 month

  4. Overall neutropenia

    Overall neutropenia ( i.e. during total chemotherapy duration) assessed from clinical hematology data and by model-based estimations of individual neutrophil curves

    Measured: 24 month

  5. Hematological / non-hematological toxicites

    Hematological (leucocytopenia, anemia, thrombocytopenia) and non-hematological toxicities (e.g. neurological, musculosceletal and gastrointestinal adverse events)

    Measured: 24 months

  6. Cumulative dose and dose intensity of paclitaxel and platinum drug

    Measured: 24 months

  7. Incidence of changes from cisplatin to carboplatin and reasons thereof

    Measured: 24 months

  8. Overall rate of febrile neutropenia and hospitalization due to chemotherapy-associated adverse events

    Measured: 24 months

  9. Health economic analysis using QoL Questionnaires

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01326767
Sponsor's protocol ID
C-III-002
Other IDs
2010-023688-16
Acronym
CEPAC-TDM
Status last verified
Jan 2016
First submitted
29 Mar 2011
Last updated
27 Jan 2016
Results posted
No
Data monitoring committee
No

Publications

  • Joerger M, von Pawel J, Kraff S, Fischer JR, Eberhardt W, Gauler TC, Mueller L, Reinmuth N, Reck M, Kimmich M, Mayer F, Kopp HG, Behringer DM, Ko YD, Hilger RA, Roessler M, Kloft C, Henrich A, Moritz B, Miller MC, Salamone SJ, Jaehde U. Open-label, randomized study of individualized, pharmacokinetically (PK)-guided dosing of paclitaxel combined with carboplatin or cisplatin in patients with advanced non-small-cell lung cancer (NSCLC). Ann Oncol. 2016 Oct;27(10):1895-902. doi: 10.1093/annonc/mdw290. Epub 2016 Aug 8.

    PubMed 27502710

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paclitaxel dosing according to SmPC and Individualized pharmacokinetically driven paclitaxel dosing in people with Carcinoma, Non-Small-Cell Lung, run by Central European Society for Anticancer Drug Research at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grad 4 Neutropenia (time frame: up to 6 weeks on treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01326767, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.

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