- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00258284
Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer
Phase II Trial of Capecitabine (Xeloda) and Weekly Docetaxel (Taxotere) in Metastatic Androgen Independent Prostate Carcinoma
RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, 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.
PURPOSE: This phase II trial is studying how well giving capecitabine together with docetaxel works in treating patients with metastatic prostate cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Determine the response rate in patients with androgen-independent metastatic adenocarcinoma of the prostate treated with capecitabine and docetaxel.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the progression-free survival, time to treatment failure, and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Michigan
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Detroit, Michigan, Estados Unidos, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
- Metastatic disease
- Androgen-independent disease
Progressive disease, as documented by ≥ 1 of the following criteria:
Rising prostate-specific antigen (PSA) despite androgen deprivation therapy and anti-androgen withdrawal
- Demonstrates a rising PSA trend with 2 successive elevations ≥ 1 week apart
- Measurable disease progression
Nonmeasurable disease progression, defined as the following:
- PSA ≥ 5 ng/mL
- New areas of bone metastases on bone scan
Serum testosterone ≤ 0.5 ng/mL (castrate level)
- Concurrent luteinizing hormone-releasing hormone agonist therapy required for medically castrated patients
PATIENT CHARACTERISTICS:
Performance status
- Zubrod 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count ≥ 1,500/ mm^3
- Hemoglobin ≥ 8.0 g/dL
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin normal
Transaminases meeting 1 of the following criteria:
- AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase (AP) normal
- AP ≤ 4 times ULN if AST and/or ALT normal
Renal
- Creatinine clearance ≥ 50 mL/min OR
- Creatinine ≤ 2 mg/dL
Cardiovascular
- No congestive heart failure
- No second- or third-degree heart block
- No myocardial infarction within the past 3 months
Other
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No other malignancy within the past 2 years except adequately treated skin cancer or other cancer in complete remission
- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- No peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
Chemotherapy
- No prior chemotherapy for metastatic disease
Endocrine therapy
- See Disease Characteristics
- More than 4 weeks since prior flutamide
- More than 6 weeks since prior bicalutamide or nilutamide
Radiotherapy
- At least 4 weeks since prior radiotherapy
Other
- At least 28 days since prior investigational drugs for prostate cancer
- No other concurrent anti-cancer therapy
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: Docetaxel & Capecitabine
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
|
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
Otros nombres:
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Response rate by RECIST criteria after every 2 courses
Periodo de tiempo: at cycle 2 and every other cycle thereafter
|
at cycle 2 and every other cycle thereafter
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Toxicity at 30 days after last treatment
Periodo de tiempo: Every week during treatment cycles
|
Every week during treatment cycles
|
|
Progression-free survival
Periodo de tiempo: Every 2 cycles
|
Every 2 cycles
|
|
Time to treatment failure
Periodo de tiempo: Every 2 cycles
|
From date of registration to date of progressive disease, or date patient is taken off study for any other reason.
|
Every 2 cycles
|
Overall survival
Periodo de tiempo: Every 2 cycles
|
Every 2 cycles
|
|
Effect of treatment on biological correlates (thymidine phosphorylase, dihydropyrimidine dehydrogenase, thymidylate synthase)
Periodo de tiempo: Every week during treatment cycles
|
Every week during treatment cycles
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Ulka N. Vaishampayan, MD, Barbara Ann Karmanos Cancer Institute
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
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias Genitales Masculinas
- Enfermedades prostáticas
- Neoplasias prostáticas
- Mecanismos moleculares de acción farmacológica
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Docetaxel
- Capecitabina
Otros números de identificación del estudio
- CDR0000445613
- P30CA022453 (Subvención/contrato del NIH de EE. UU.)
- WSU-D-2615
- WSU-HIC-067903MP4F
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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