- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00448760
Combination Chemotherapy in Treating Patients With Previously Untreated Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery
A Nonrandomized Phase II Study: Feasibility and Outcome of Neo Adjuvant Chemotherapy With Oxaliplatin, Fluorodeoxyuridine (FUdR), Taxotere and Leucovorin in the Treatment of Previously Untreated Advanced Esophago-Gastric Carcinoma
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, floxuridine, docetaxel, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with previously untreated stage II or stage III esophageal cancer that can be removed by surgery.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
OBJECTIVES:
Primary
- Determine whether neoadjuvant chemotherapy comprising oxaliplatin, floxuridine, docetaxel, and leucovorin calcium improves the rate of pathologic complete response in patients with previously untreated, resectable stage II or III adenocarcinoma of the esophagus.
Secondary
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the clinical response rates (complete response and partial response) in patients treated with this regimen.
- Evaluate thymidylate synthase (TS), mRNA gene expression, TS activity, and TS and mRNA sequence, to determine the altered spots as related to drug resistance in these patients.
- Evaluate the potential for genome-wide gene expression profiling to predict response to therapy, recurrence, progression-free survival, overall survival, and drug sensitivity and resistance in these patients.
- Define the role of 5' untranslated region (5'-UTR) on translation and drug resistance in these patients.
- Evaluate, by bone marrow aspirate analysis and flow cytometry, the initial presence of cancer cells in the marrow, and clearance of these cells after treatment with this regimen.
- Evaluate the safety of this regimen in these patients.
- Assess quality of life of patients during and after treatment with this regimen.
OUTLINE: This is a nonrandomized, open-label study.
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and docetaxel IV over 30 minutes, floxuridine IV over 24 hours, and leucovorin calcium IV over 24 hours on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo surgery after completion of chemotherapy. Patients who achieve pathologic complete response (pCR) receive no further chemotherapy. Patients who have not achieved a pCR receive 2 courses of adjuvant chemotherapy (same regimen as the neoadjuvant chemotherapy) beginning 3 weeks after surgery.
Patients undergo blood and tissue collection periodically for correlative studies. Samples are analyzed for thymidylate synthase (TS), mRNA gene expression, TS activity, and TS and mRNA sequence by bone marrow aspirate, flow cytometry, and quantitative reverse transcriptase-polymerase chain reaction.
Quality of life will be assessed at baseline, after neoadjuvant chemotherapy, after adjuvant therapy, and at the first 3-month follow-up visit.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Florida
-
Miami, Florida, Estados Unidos, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Diagnosis of adenocarcinoma of the esophagus meeting the following criteria:
- Stage II or III disease
- Resectable disease
- Previously untreated disease
- No stage I (mucosal only) or stage IV (metastatic) disease
PATIENT CHARACTERISTICS:
- WBC > 3,000/mm^3
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Creatinine ≤ 2.0 mg/dL
- Bilirubin < 2 times normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must have central venous access
- No other malignancy within the past 5 years
- No concurrent medical or psychiatric problem that would preclude study treatment
- No contraindications to paclitaxel
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy to the esophagus
- No oral cryotherapy (e.g., ice chips) on day 1 of each course
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: Neoadjuvant + Adjuvant Chemotherapy
|
Intravenously, 25 mg/m2, over 30 minutes, 2 cycles
Otros nombres:
Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles
Otros nombres:
Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles
Intravenously, 85 mg/m2, over 2 hours, 2 cycles
Analysis of tumor for pathologic response to protocol therapy
Analysis of tumor for pathologic response to protocol therapy
Surgical removal of tumor for correlative studies
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pathologic Complete Response
Periodo de tiempo: 8 - 16 weeks
|
No evidence of cellular residual cancerous cells as evidenced by tumor tissue samples taken via surgery at the end of neo-adjuvant chemotherapy.
|
8 - 16 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Sobrevivencia promedio
Periodo de tiempo: 24 meses
|
24 meses
|
|
Clinical Response
Periodo de tiempo: 8 - 16 weeks
|
Overall response = Complete response (CR) + Partial Response (PR). Evaluated via endoscopic ultrasounds, PET and CT scans of the chest: Complete Response (CR) applies to participants complete disappearance of all measurable and evaluable disease. No new lesion. No disease related symptoms. No evidence of non-evaluable disease, including tumor markers and other laboratory values. Partial Response (PR) applies to participants with at least 50 percent reduction in the sum of the products of bi-dimensional perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. |
8 - 16 weeks
|
Median Progression-free Survival (PFS)
Periodo de tiempo: 24 months
|
24 months
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
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
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes Protectores
- Micronutrientes
- Vitaminas
- Antídotos
- Complejo de vitamina B
- Docetaxel
- Oxaliplatino
- Leucovorina
- Floxuridina
Otros números de identificación del estudio
- 20040006
- SCCC-2003151 (Otro identificador: University of Miami Sylvester Comprehensive Cancer Center)
- WIRB-20051464 (Otro identificador: Western Institutional Review Board)
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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