Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer (TPEx)
7 avril 2017 mis à jour par: Groupe Oncologie Radiotherapie Tete et Cou
Phase II Study of Cetuximab, Docetaxel and Cisplatin as First-line Treatment in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinomas - GORTEC 2008-03 TPEx
PURPOSE: Cetuximab with platinum and 5FU is now the standard combination as first-line treatment in patients with metastatic or recurrent Head and Neck squamous cell carcinomas.
Cetuximab and taxane combinations have demonstrated promising activity in Head and Neck cancer.
This phase II trial is studying new cetuximab, docetaxel and cisplatin combination named TPEx as first-line treatment in this setting.
Aperçu de l'étude
Statut
Complété
Intervention / Traitement
Description détaillée
OBJECTIVES:
Primary
- To determine the efficacy of TPEx combination in patients with head and neck cancer in term of objective response rate (RECIST, see statistical consideration) Secondary
- To assess toxicities of TPEx combination
- Determine the efficacy of TPEx combination in patients with head and neck cancer: Best Overall Response , progression-free survival and survival.
- Translational research objective:To better understand the mechanisms of chemoresistance and to identify biomarkers by the analysis of the tumor biopsies (RNA, gene expression profile) and protein profile (plasma samples). Exploratory analyses.
OUTLINE: This is an open-label phase II, multicenter study. Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator. Tumor check-up will be performed every 6 weeks. This study will allow translational research with blood sample and biopsies at baseline before any treatment, during the treatment with TPEx combination (week 6).,After completion of study treatment, patients are followed every 2 months.
Type d'étude
Interventionnel
Inscription (Réel)
54
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Bruxelles, Belgique
- Cliniques Universitaires
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Namur, Belgique
- Clinique Sainte Elisabeth
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Yvoir, Belgique
- Clinique universitaire de Mont Godinne UCL
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Bordeaux, France
- Hopital Saint André
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Clermont-Ferrand, France
- Centre Jean Perrin,
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Dijon, France
- Centre G-F Leclerc
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Draguignan, France
- Centre Hospitalier de la Dracénie
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Lorient, France
- Centre Hospitalier de Bretagne Sud
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Lyon, France
- Centre Léon Bérard
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Marseille, France
- Hôpital de la Timone
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Rouen, France
- Centre Henri Becquerel
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Suresnes, France
- Hôpital Foch
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Tours, France
- CHU Bretonneau
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Villejuif, France
- Institut Gustave Roussy
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 70 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Histologically proven squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx
- Recurrent disease, incurable disease as determined by surgery or radiation, or metastatic disease
- Measurable or evaluable disease
- Age > 18 years and <= 70 years
- WHO performance status 0 or 1
- Absolute neutrophil count > 1,500/mm3
- Platelets > 150,000/mm3
- Total Bilirubin <= institutional upper limit of normal
- Aspartate aminotransferase < 1.5 X institutional upper limit of normal
- Alanine aminotransferase < 1.5 X institutional upper limit of normal
- Alkaline phosphatase < 2.5 X institutional upper limit of normal
- creatinine clearance > 60 mL/min
- Signed informed consent
- Women of child-bearing potential and men must be willing and able practice adequate contraception prior to study entry and for the duration of study treatment
Exclusion Criteria:
- Previous chemotherapy. Chemotherapy given as part of initial curative therapy and completed more than 6 months before inclusion is allowed
- Previous treatment with total doses of cisplatin > 300 mg/ m2
- Patients must not have any co-existing disease that would preclude cisplatin administration, such as peripheral neuropathy or renal failure
- Surgery (excluding biopsy) or radiotherapy within 4 weeks prior to study entry
- Nasopharyngeal carcinoma, or cancer of sinusal cavities
- Active infection including tuberculosis or HIV positive patient
- Other malignancy within last 5 years except for non-melanoma skin cancer
- No other investigational agent within 30 days prior to study entry
- No other concurrent chemotherapy, immunotherapy, antitumor hormonal therapy (excluding contraceptives and replacement steroids), radiotherapy, or experimental medications
- No prior anti EGFR therapy
- No known brain metastases
- Uncontrolled intercurrent illness that would prevent delivery of protocol therapy
- Patients with a prior history of basal cell carcinoma of the skin or in situ carcinoma of the cervix must have been curatively treated and must have remained disease free for 5 years post diagnosis
- No history of hypersensitivity reaction to drugs on study
- No unstable angina or myocardial infarction within the past 12 months
- No symptomatic congestive heart failure or New York Heart Association (NYHA) class II-IV heart disease
- No serious uncontrolled cardiac arrhythmia
- No other prior or concomitant squamous cell carcinoma
- No other prior or concomitant cancer, except curatively treated basal carcinoma of the skin or in situ cervical cancer, for which the patient has been curatively treated and remains disease-free for the past 5 years
- Patient is pregnant or lactating
- Patients must not have any co-existing condition that would preclude full compliance with the study
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: cetuximab
Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1.
Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks.
Treatment will be continued until disease progression or unacceptable toxicities according
|
Drug: Cisplatin IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy.
No intervention, only biopsy for translational project.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Objective Tumor Response Rate
Délai: 12 weeks (after completion of the 4th cycle of chemotherapy)
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The objective tumor response rate is evaluated every 6 weeks according to RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT-scan or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. |
12 weeks (after completion of the 4th cycle of chemotherapy)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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La survie globale
Délai: 1 an
|
1 an
|
|
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Survie sans progression
Délai: 1 an
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1 an
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|
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Grade 1 to 5 Toxicity
Délai: 24 weeks (average)
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All grade 1 to 5 toxicity are registered during treatment.
Patients have weekly clinical and biological examination.
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24 weeks (average)
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Best Overall Response
Délai: 12 weeks
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Tumor response is evaluated every 6 weeks according to RECIST criteria.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, Stable Disease (SD); Best overall Response = CR + PR + SD.
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12 weeks
|
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Biomarkers
Délai: two years
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two years
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chaise d'étude: Joel GUIGAY, GORTEC
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2009
Achèvement primaire (Réel)
1 janvier 2014
Achèvement de l'étude (Réel)
1 janvier 2014
Dates d'inscription aux études
Première soumission
1 février 2011
Première soumission répondant aux critères de contrôle qualité
2 février 2011
Première publication (Estimation)
3 février 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 mai 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 avril 2017
Dernière vérification
1 octobre 2016
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GORTEC 2008-03 TPEx
- 2008-004869-25 (Numéro EudraCT)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .