- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00276055
Phase IB Study of Gemcitabine, Docetaxel and Bevacizumab in Patients With Soft Tissue Sarcoma
1.1 To determine the recommended phase II dose for gemcitabine in combination with a fixed dose of docetaxel and bevacizumab.
1.2 To determine the efficacy of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma 1.3 To determine the toxicity profile of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New Mexico
-
Albuquerque, New Mexico, Estados Unidos, 87131
- University of New Mexico
-
Albuquerque, New Mexico, Estados Unidos, 87102-3661
- Hematology Oncology Associates
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Santa Fe, New Mexico, Estados Unidos, 87505
- St. Vincent Regional Medical Center
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Santa Fe, New Mexico, Estados Unidos, 87508
- New Mexico Cancer Care Associates
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
- All patients, 18 years of age or older, with chemotherapy naive soft tissue sarcoma are eligible if there is measurable disease Prior surgery or radiotherapy for the primary tumor is allowed but needs to have been completed at least 2 weeks from entry, and patient should have completely recovered from the procedures.
- Patients must have a life expectancy of at least 12 weeks.
- Patients must have a Zubrod performance status of 0-2.
- Patients must sign an informed consent.
- Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 and absence of a regular red blood cell transfusion requirement.
- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine < 1.5 x upper limit of normal.
Exclusion Criteria:
- Patients with symptomatic brain metastases are excluded from this study.
- Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
- Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
- Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Cohort 1
1000mg/m2 gemcitabine
|
During the treatment phase, pts.
will receive the drug combination of gemcitabine, docetaxel, and bevacizumab every 2 weeks for a period of 4 weeks.
This 4-week period is called a cycle of treatment.
The treatment consists of receiving docetaxel IV over a 60-minute period and gemcitabine IV over a 30-minute period.
Pts. will then receive bevacizumab IV over a 30-minute period.
Pts. will receive this treatment once every 2 weeks.
Pts. will receive at least 2 cycles of treatment unless you have progression of your disease or unmanageable side effects.
As long as the size of pts.'s tumor stays the same or gets smaller, pts may continue receiving treatment
Otros nombres:
|
Experimental: Cohort 2
1250 mg/m2 gemcitabine
|
During the treatment phase, pts.
will receive the drug combination of gemcitabine, docetaxel, and bevacizumab every 2 weeks for a period of 4 weeks.
This 4-week period is called a cycle of treatment.
The treatment consists of receiving docetaxel IV over a 60-minute period and gemcitabine IV over a 30-minute period.
Pts. will then receive bevacizumab IV over a 30-minute period.
Pts. will receive this treatment once every 2 weeks.
Pts. will receive at least 2 cycles of treatment unless you have progression of your disease or unmanageable side effects.
As long as the size of pts.'s tumor stays the same or gets smaller, pts may continue receiving treatment
Otros nombres:
|
Experimental: Cohort 3
1500 mg/m2 gemcitabine
|
During the treatment phase, pts.
will receive the drug combination of gemcitabine, docetaxel, and bevacizumab every 2 weeks for a period of 4 weeks.
This 4-week period is called a cycle of treatment.
The treatment consists of receiving docetaxel IV over a 60-minute period and gemcitabine IV over a 30-minute period.
Pts. will then receive bevacizumab IV over a 30-minute period.
Pts. will receive this treatment once every 2 weeks.
Pts. will receive at least 2 cycles of treatment unless you have progression of your disease or unmanageable side effects.
As long as the size of pts.'s tumor stays the same or gets smaller, pts may continue receiving treatment
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Overall response rate (complete and partial responses).
Periodo de tiempo: 4 years
|
Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0).
ORR is the sum of the percentages of patients achieving complete and partial responses
|
4 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Claire Verschraegen, MD, University of New Mexico
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
- Neoplasias De Tejidos Conectivos Y Blandos
- Neoplasias por tipo histológico
- Neoplasias
- Sarcoma
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Inhibidores de enzimas
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Gemcitabina
- Docetaxel
- Bevacizumab
Otros números de identificación del estudio
- INST 0509C
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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