- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01067053
Efficacy/Safety Study of Bevacizumab,Capecitabine,Oxaliplatin to Metastatic Colorectal Adenocarcinoma Elderly Patients. (BECOX)
A Non Randomized Phase II Trial to Assess Efficacy and Safety of Bevacizumab, Capecitabine and Oxaliplatin as First Line Treatment for Elderly Patients With Metastatic Colorectal Adenocarcinoma, Suitable for Polychemotherapy Treatment
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The efficacy will be determined by objective response rate following RECIST criteria.
In several clinical trials with Bevacizumab, there has been demonstrated that elderly patients benefits as well as the younger of a combination therapy with chemotherapy plus Bevacizumab, but these results have come from subgroup analyses of trials not specifically design to test the effect of these combinations on the elderly. This clinical trial is specific only for elderly patients and we expect to confirm the benefits demonstrated in other clinical trials where the elderly patients were a number reduced.
This clinical trial includes 3 substudies:
- Assessment of tumor response of CRC liver metastases to treatment with Avastin in combination with Capecitabine and Oxaliplatin as first line treatment by dynamic ultrasound contrast.
Main objective: Assess the performance of dynamic contrast ultrasonography (CEUS, Contrast Enhanced UltraSound) with quantification of tumor perfusion in the evaluation of tumor response of liver metastases of colorectal carcinoma to treatment with Avastin in combination with Capecitabine and Oxaliplatin.
-Evaluation of the antiangiogenic activity of bevacizumab combined with oxaliplatin and capecitabine in first line treatment using MDCT perfusion studies in liver metastases of colorectal cancer in patients over 70 years.
Main objective:Determine whether the observed changes in perfusion CT studies performed at 2 weeks of starting treatment compared to baseline are significant predictors of free time to disease progression in patients in the trial and defined as the time since the start of treatment until objective progressive disease by RECIST criteria.
-Characterization of resistance to bevacizumab in colon cancer in elderly patients.
Main objective: To evaluate the involvement of serum markers and markers in the primary tumor in the resistance to bevacizumab.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Barcelona, España, 08036
- Hospital Clinic i Provincial
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Burgos, España, 09005
- Hospital General Yagüe
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Lérida, España, 25198
- Hospital Arnau de Vilanova
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Madrid, España, 28046
- Hospital Universitario La Paz
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Madrid, España, 28223
- Hospital Quirón de Madrid
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Murcia, España, 30008
- Hospital Morales Meseguer
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Valencia, España, 46009
- Hospital La Fe de Valencia
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Valencia, España, 46014
- Hospital General de Valencia
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Valencia, España, 46017
- Hospital Doctor Peset
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Vigo, España, 36204
- Hospital Xeral Cies de Vigo
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Barcelona
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Hospitalet de Llobregat, Barcelona, España, 08906
- Hospital de L´Hospitalet
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Las Palmas
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Las Palmas de Gran Canaria, Las Palmas, España, 35010
- Hospital de Gran Canaria Doctor Negrin
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Madrid
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San Sebastián de los Reyes, Madrid, España, 28702
- Hospital Infanta Sofia
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Navarra
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Pamplona, Navarra, España, 31008
- Hospital de Navarra
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Valencia
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Játiva, Valencia, España, 46800
- Hospital Lluis Alcanyis
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Written informed consent.
- ECOG 0-1.
- Age ≥ 70 years.
- Histologically confirmed carcinoma of the colon and/or rectum.
- Metastatic disease non suitable for radical surgery.
- At least one measurable metastatic lesion (as per RECIST criteria). The index lesion must not be in a previously irradiated area.
- Non prior chemotherapy for metastatic disease. Adjuvant (or neo-adjuvant for rectal cancer patients) chemotherapy allowed if completed ≥ 12 months before inclusion.
- Life expectancy more than 3 months.
- Adequate renal function: creatinine ≤ 1.5 x UL and calculated creatinine clearance ≥ 30 mL/min.
- Adequate level function: AST and ALT ≤ 2.5 x UL (≤ 5 x UL if liver metastases), bilirubin ≤ 1.5 x UL.
- Adequate haematological function: Hb ≥ 9 gr/dl, neutrophils ≥ 1,5 x 109 /l and platelets ≥ 100000 x 109/l.
- Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24 hour urine must demonstrate ≤ 1 g of protein in 24 hours.
- No clinical evidence or history of metastatic CNS disease.
- No prior Bevacizumab treatment.
Exclusion Criteria:
- Patients who previously received bevacizumab.
- Prior chemotherapeutic treatment for metastatic CRC.
- Prior treatment with monoclonal antibodies.
- Clinical evidence of brain metastases or history or evidence upon physical examination of CNS disease unless adequately treated.
- Past or current history (within the last 5 years prior to treatment start) of other malignancies except metastatic colorectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
- Clinically significant cardiovascular disease, for example CVA (≤ 6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2, CHF, arrhythmia requiring medication, or uncontrolled hypertension.
- Intestinal occlusion/subocclusion.
- Chronic diarrhea.
- Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study.
- Known hypersensitivity to any of the study drugs.
- Current or recent (within 10 days of first dose of study treatment) daily use of aspirin (> 325 mg/day) or other NSAID.
- Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes. Patients receiving (or considered candidate to receive) anticoagulants agents as prophylaxis of cardiovascular risk, should continue (or start) the appropriate treatment at study entry.
- History of venous thromboembolic or haemorrhagic events within 6 months prior to treatment.
- Patients with previous of arterial thromboembolic event.
- Evidence of bleeding diathesis or coagulopathy.
- Serious, non healing wound, ulcer, or bone fracture.
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or anticipation of the need for major surgery during the course of the study.
- Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
- Patients of childbearing potential not willing to use effective means of contraception.
- Positive HIV serology.
- Known addiction to alcohol or other drugs.
- Patients included in other clinical trial
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: bevacizumab, capecitabine, oxaliplatin
6 cycles (3 weeks each one) of:
After the first 6 cycles of treatment, continuing only with bevacizumab and capecitabine |
6 cycles (3 weeks each one) of:
After the first 6 cycles of treatment, continuing only with bevacizumab and capecitabine
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Tiempo de progresión
Periodo de tiempo: 3 años
|
3 años
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Sobrevivencia promedio
Periodo de tiempo: 3 años
|
3 años
|
Tasa de respuesta general
Periodo de tiempo: 3 años
|
3 años
|
Objective response rate following Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Periodo de tiempo: 3 years
|
3 years
|
Number of treatment cycles administered
Periodo de tiempo: 3 years
|
3 years
|
Number of patients who have required dose reductions of either drug
Periodo de tiempo: 3 years
|
3 years
|
Safety of treatment according to the number of adverse events reported
Periodo de tiempo: 3 yeras
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3 yeras
|
Colaboradores e Investigadores
Investigadores
- Silla de estudio: Jaime Feliu Batlle, MD, Grupo Español Multidisciplinario de Cáncer Digestivo
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
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 por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Carcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Colon
- Enfermedades intestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Neoplasias colorrectales
- Adenocarcinoma
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes antineoplásicos inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Capecitabina
- Oxaliplatino
- Bevacizumab
Otros números de identificación del estudio
- GEMCAD-0901
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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