- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00445861
Cetuximab, Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery
Cetuximab in Combination With Radiation Therapy and Chemotherapy Prior to Surgery in Patients With Resectable, Locally Advanced Esophageal Carcinoma. A Multicenter Phase IB-II Trial
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab, docetaxel, and cisplatin together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I/II trial is studying the side effects of cetuximab, docetaxel, cisplatin, and radiation therapy and to see how well they work in treating patients with locally advanced esophageal cancer that can be removed by surgery.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
OBJECTIVES:
Primary
- Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin in patients with resectable locally advanced esophageal cancer.
Secondary
- Determine the feasibility and efficacy of this regimen in these patients.
- Determine the duration of response and patterns of failure in patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Chemoimmunotherapy: Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-3 and docetaxel IV over 1 hour and cisplatin IV over 1 hour once in week 1. Treatment repeats every 3 weeks for 2 courses.
Chemoimmunotherapy and radiotherapy: Patients are sequentially assigned to 1 of 2 treatment levels.
- Treatment level 1: Patients receive cetuximab IV over 1 hour once weekly, cisplatin IV over 1 hour once weekly, and undergo radiotherapy once daily, 5 days a week, in weeks 7-11.
- Treatment level 2: Patients receive cetuximab, cisplatin, and radiotherapy as in treatment level 1. Patients also receive docetaxel IV over 1-2 hours once weekly in weeks 7-11.
Cohorts of 7-20 patients are treated at treatment level 1 or 2 sequentially, as long as no more than 2 of 7 patients experience dose-limiting toxicity (DLT), until the safe treatment level for future study is determined. The safe treatment level is defined as the level at which no more than 2 of 7 and no more than 6 of 20 patients experience DLT. At least 20 patients are treated at the safe treatment level.
- Surgery: Between 4-8 weeks after completion of neoadjuvant chemoimmunotherapy and radiotherapy, patients undergo surgery.
After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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St. Gallen, Suiza, CH-9007
- Kantonsspital - St. Gallen
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St. Gallen, Suiza, Ch-9016
- Klinik Stephanshorn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus
- Carcinoma of the gastroesophageal junction (i.e., Siewert staging system type I disease) allowed
Locally advanced disease
- Obstructive tumors are considered locally advanced disease
Meets 1 of the following staging criteria:
- T3, N0 disease
- T1-3, N1 disease
- T4, N0-1 disease
Resectable disease
- No T4 (unequivocal organ involvement) disease that cannot be resected with curative intent
- No airway infiltration in case of tumors of the upper third of the thoracic esophagus
- No cervical esophageal carcinoma
- No distant metastasis, including stage M1a (celiac node involvement) by fine-needle aspiration or biopsy
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Creatinine clearance > 60 mL/min
- Bilirubin normal
- Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
- AST ≤ 1.5 times ULN
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 12 months after completion of study treatment
- No other malignancy within the past 5 years except nonmelanomatous skin cancer or adequately treated in situ cervical cancer
No severe or uncontrolled cardiovascular disease including, but not limited to, any of the following:
- New York Heart Association class III or IV congestive heart failure
- Unstable angina pectoris
- Myocardial infarction within the past 3 months
- Significant arrhythmias
- No psychiatric disorder that would preclude study compliance
- No active uncontrolled infection
- No serious underlying medical condition that, in the opinion of the investigator, would interfere with study participation (e.g., uncontrolled diabetes mellitus or active autoimmune disease)
- No peripheral neuropathy > grade 1
- No contraindications to corticosteroids
- No known hypersensitivity to any component of the study drugs
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No prior radiotherapy to the chest
- No participation in another clinical trial within the past 30 days
- No other concurrent experimental drugs or anticancer therapy
- No concurrent drugs contraindicated for use with the study drugs
Plan de estudios
¿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)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin
Periodo de tiempo: Until treatment ends
|
Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin
|
Until treatment ends
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Determine the feasibility and efficacy of the study's regimen
Periodo de tiempo: Until trial ends
|
Determine the feasibility and efficacy of this regimen in these patients.
|
Until trial ends
|
Determine the duration of response and patterns of failure
Periodo de tiempo: Until trial ends
|
Determine the duration of response and patterns of failure in patients treated with this regimen
|
Until trial ends
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Thomas Ruhstaller, MD, Cantonal Hospital of St. Gallen
Publicaciones y enlaces útiles
Publicaciones Generales
- Steffen T, Dietrich D, Schnider A, Kettelhack C, Huber O, Marti WR, Furrer M, Gloor B, Schiesser M, Thierstein S, Brauchli P, Ruhstaller T; Swiss Group for Clinical Cancer Research (SAKK). Recurrence Patterns and Long-term Results After Induction Chemotherapy, Chemoradiotherapy, and Curative Surgery in Patients With Locally Advanced Esophageal Cancer. Ann Surg. 2019 Jan;269(1):83-87. doi: 10.1097/SLA.0000000000002435.
- Ruhstaller T, Pless M, Dietrich D, Kranzbuehler H, von Moos R, Moosmann P, Montemurro M, Schneider PM, Rauch D, Gautschi O, Mingrone W, Widmer L, Inauen R, Brauchli P, Hess V. Cetuximab in combination with chemoradiotherapy before surgery in patients with resectable, locally advanced esophageal carcinoma: a prospective, multicenter phase IB/II Trial (SAKK 75/06). J Clin Oncol. 2011 Feb 20;29(6):626-31. doi: 10.1200/JCO.2010.31.9715. Epub 2011 Jan 4.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias
- Neoplasias por sitio
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias de Cabeza y Cuello
- Enfermedades esofágicas
- Neoplasias Esofágicas
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos inmunológicos
- Docetaxel
- Cetuximab
Otros números de identificación del estudio
- SAKK 75/06
- EU-20702
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. .
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