- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01326767
Central European Society for Anticancer Research (CESAR) Study of Paclitaxel Therapeutic Drug Monitoring (CEPAC-TDM)
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Bochum, Allemagne
- CESAR Study Center
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Bonn, Allemagne
- CESAR Study Center
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Essen, Allemagne
- CESAR Study Center
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Gerlingen, Allemagne
- CESAR Study Center
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Großhansdorf, Allemagne
- CESAR Study Center
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Halle an der Saale, Allemagne
- CESAR Study Center
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Leer, Allemagne
- CESAR Study Center
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Löwenstein, Allemagne
- CESAR Study Center
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Munich, Allemagne
- CESAR Study Center
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Tübingen, Allemagne
- CESAR Study Center
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St. Gallen, Suisse, 9007
- Kantonsspital St. Gallen
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Paclitaxel dosing according to SmPC
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Paclitaxel i.V. Up to 6 cycles Dosing according to SmPC
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Expérimental: 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.
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Paclitaxel i.V. Up to 6 cycles Dosing based on patient age, gender, severity of neutropenia and Paclitaxel plasma concentration
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Grad 4 Neutropenia
Délai: up to 6 weeks on treatment
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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.
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up to 6 weeks on treatment
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Objective tumor response according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST v1.1)
Délai: 24 months
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24 months
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Progression free survival
Délai: 24 month
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24 month
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Overall survival
Délai: 24 month
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24 month
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Overall neutropenia
Délai: 24 month
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Overall neutropenia ( i.e. during total chemotherapy duration) assessed from clinical hematology data and by model-based estimations of individual neutrophil curves
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24 month
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Hematological / non-hematological toxicites
Délai: 24 months
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Hematological (leucocytopenia, anemia, thrombocytopenia) and non-hematological toxicities (e.g.
neurological, musculosceletal and gastrointestinal adverse events)
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24 months
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Cumulative dose and dose intensity of paclitaxel and platinum drug
Délai: 24 months
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24 months
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Incidence of changes from cisplatin to carboplatin and reasons thereof
Délai: 24 months
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24 months
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Overall rate of febrile neutropenia and hospitalization due to chemotherapy-associated adverse events
Délai: 24 months
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24 months
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Health economic analysis using QoL Questionnaires
Délai: 24 months
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24 months
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chaise d'étude: Markus Joerger, MD PhD, Central European Society for Anticancer Drug Research
- Directeur d'études: Ulrich Jaehde, PhD, Central European Society for Anticancer Drug Research
- Chercheur principal: Frank Mayer, MD, Eberhard-Karls-Universität Tübingen
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Tumeurs
- Maladies pulmonaires
- Tumeurs par site
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Carcinome bronchique
- Tumeurs bronchiques
- Tumeurs pulmonaires
- Carcinome pulmonaire non à petites cellules
- Mécanismes moléculaires de l'action pharmacologique
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Agents antinéoplasiques phytogéniques
- Paclitaxel
- Paclitaxel lié à l'albumine
Autres numéros d'identification d'étude
- C-III-002
- 2010-023688-16 (Numéro EudraCT)
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