- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00084773
Neoadjuvant Cetuximab, Fluorouracil, and Pelvic Irradiation in Treating Patients With Locally Advanced or Locally Recurrent Rectal Cancer
A Pilot Clinical Trial of Preoperative Cetuximab With Concurrent Continuous Infusion Fluorouracil and Pelvic Radiation in Patients With Local-Regionally Advanced Rectal Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Determine the safety profile of neoadjuvant cetuximab, fluorouracil, and pelvic irradiation in patients with locally advanced or locally recurrent rectal cancer.
Secondary
- Determine the activity of this regimen, in terms of pathological complete response rate, in these patients.
OUTLINE: This is a non-randomized, open-label, pilot study.
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64 and fluorouracil IV continuously on days 1-42. Patients undergo whole-pelvic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Treatment continues in the absence of disease progression or unacceptable toxicity.
Approximately 1-3 weeks after completion of study treatment, patients undergo surgical resection followed by adjuvant chemotherapy off-study.
Patients are followed for up to 5 years.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically confirmed rectal adenocarcinoma meeting 1 of the following staging criteria:
Locally advanced disease
Resectable (uT3) disease
- Primary gross transmural tumor that is not adherent to adjacent pelvic structures by endorectal ultrasound
Primary tethered or unresectable (cT4 or uT4) disease
- Primary tumor is contiguous with or adherent or fixed to adjacent pelvic structures by clinical exam and CT scan
- Primary surgery would likely leave residual tumor
- Small volume extrapelvic metastases allowed
Recurrent disease after definitive resection
- Disease limited to the pelvis
- Requires combined modality treatment
- Epidermal growth factor receptor status-positive, -negative, or -unknown
- If previously treated with adjuvant fluorouracil-based chemotherapy, no disease recurrence during or within 12 months after completion of adjuvant therapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0 -1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Hemoglobin > 8.0 g/dL
- Platelet count > 150,000/mm^3
Hepatic
- Not specified
Renal
- Creatinine ≤ 1.5 times upper limit of normal
Cardiovascular
- No myocardial infarction within the past 6 months
- No evidence of uncontrolled congestive heart failure requiring therapy
Other
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No known severe hypersensitivity to cetuximab or any of its excipients
- No uncontrolled infection
- No high-grade bowel obstruction (bowel lumen ≤ 1 cm) unless patient has undergone protective surgical diversion or endoscopic stenting procedure
- No other concurrent medical or psychiatric condition or disease that would preclude study participation
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior cetuximab
- No prior murine or chimeric monoclonal antibody therapy
- No prior biological response modifiers for metastatic colorectal cancer
- No concurrent anti-vascular endothelial growth factor/Flk-1 monoclonal antibody therapy
- No other concurrent antibody therapy or immunotherapy
- No concurrent gene therapy
- No concurrent vaccine therapy
- No concurrent angiogenesis inhibitors, including thalidomide
Chemotherapy
- See Disease Characteristics
- No prior chemotherapy for metastatic colorectal cancer
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent hormonal therapy
Radiotherapy
- No prior radiotherapy for metastatic colorectal cancer
- No prior pelvic radiotherapy
- No other concurrent radiotherapy
Surgery
- See Disease Characteristics
- Fully recovered from prior oncologic or other major surgery
Other
- No other prior therapy that targets the epidermal growth factor receptor pathway
- No other concurrent experimental therapy or drugs
- No concurrent matrix metalloprotease inhibitors
- No concurrent participation in another clinical study
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)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Cetuximab, Fluorouracil, and Pelvic Irradiation
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64 and fluorouracil IV continuously on days 1-42. Patients undergo whole-pelvic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Treatment continues in the absence of disease progression or unacceptable toxicity. Approximately 1-3 weeks after completion of study treatment, patients undergo surgical resection followed by adjuvant chemotherapy off-study. Patients are followed for up to 5 years. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Safety profile
Periodo de tiempo: 2 years
|
2 years
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Activity in terms of pathological complete response rate
Periodo de tiempo: 2 years
|
2 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Leonard B. Saltz, MD, Memorial Sloan Kettering Cancer Center
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
- Enfermedades intestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Neoplasias colorrectales
- Neoplasias Rectales
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes antineoplásicos inmunológicos
- Fluorouracilo
- Cetuximab
Otros números de identificación del estudio
- 04-006
- MSKCC-04006
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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