Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer (TPEx)
7 de abril de 2017 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
54
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Bruxelles, Bélgica
- Cliniques Universitaires
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Namur, Bélgica
- Clinique Sainte Elisabeth
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Yvoir, Bélgica
- Clinique universitaire de Mont Godinne UCL
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Bordeaux, Francia
- Hopital Saint André
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Clermont-Ferrand, Francia
- Centre Jean Perrin,
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Dijon, Francia
- Centre G-F Leclerc
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Draguignan, Francia
- Centre Hospitalier de la Dracénie
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Lorient, Francia
- Centre Hospitalier de Bretagne Sud
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Lyon, Francia
- Centre Léon Bérard
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Marseille, Francia
- Hôpital de la Timone
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Rouen, Francia
- Centre Henri Becquerel
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Suresnes, Francia
- Hôpital Foch
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Tours, Francia
- CHU Bretonneau
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Villejuif, Francia
- Institut Gustave Roussy
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Objective Tumor Response Rate
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sobrevivencia promedio
Periodo de tiempo: 1 año
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1 año
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Supervivencia libre de progresión
Periodo de tiempo: 1 año
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1 año
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Grade 1 to 5 Toxicity
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: two years
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two years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Joel GUIGAY, GORTEC
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2009
Finalización primaria (Actual)
1 de enero de 2014
Finalización del estudio (Actual)
1 de enero de 2014
Fechas de registro del estudio
Enviado por primera vez
1 de febrero de 2011
Primero enviado que cumplió con los criterios de control de calidad
2 de febrero de 2011
Publicado por primera vez (Estimar)
3 de febrero de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de mayo de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
7 de abril de 2017
Última verificación
1 de octubre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GORTEC 2008-03 TPEx
- 2008-004869-25 (Número EudraCT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .