- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00016952
Irinotecan or Fluorouracil Plus Leucovorin in Treating Patients With Previously Treated Metastatic Colorectal Cancer
Phase II Study in Patients With Metastatic Colorectal Carcinoma Previously Treated With Oxaliplatin (OXAL) or a Combination of Irinotecan (CPT-11) and OXAL
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.
PURPOSE: Phase II trial to compare the effectiveness of either irinotecan or fluorouracil plus leucovorin in treating patients who have metastatic colorectal cancer that has been previously treated with oxaliplatin with or without irinotecan.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Determine the tumor response rate in patients receiving irinotecan or fluorouracil and leucovorin calcium for metastatic colorectal cancer previously treated with oxaliplatin with or without irinotecan.
- Determine the time to tumor progression, time to treatment failure, and overall survival of patients treated with these regimens.
- Determine the toxic effects of these regimens in these patients.
- Evaluate the quality of life of patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (oxaliplatin-based therapy vs irinotecan and oxaliplatin combination therapy). Patients are assigned to one of two treatment groups.
- Group I (prior oxaliplatin-based chemotherapy): Patients receive irinotecan IV over 90 minutes on day 1. Treatment repeats every 3 weeks.
- Group II (prior irinotecan and oxaliplatin combination chemotherapy): Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously on days 1 and 2. Treatment repeats every 2 weeks.
- Both groups: Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a confirmed complete response for 2 consecutive courses may discontinue treatment at investigator's discretion.
Quality of life is assessed at baseline, approximately every 6 weeks during treatment, and then after the last course of treatment.
Patients are followed every 3 months for 5 years.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Saskatchewan
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Regina, Saskatchewan, Canadá, S4T 7T1
- Allan Blair Cancer Centre
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259-5404
- CCOP - Scottsdale Oncology Program
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Florida
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Jacksonville, Florida, Estados Unidos, 32224
- Mayo Clinic
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Illinois
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Peoria, Illinois, Estados Unidos, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, Estados Unidos, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, Estados Unidos, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, Estados Unidos, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, Estados Unidos, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, Estados Unidos, 67214-3882
- CCOP - Wichita
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106
- CCOP - Ann Arbor Regional
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68106
- CCOP - Missouri Valley Cancer Consortium
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South Dakota
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Rapid City, South Dakota, Estados Unidos, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Estados Unidos, 57104
- CCOP - Sioux Community Cancer Consortium
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
- Diagnosis of metastatic colorectal adenocarcinoma incurable by surgery or not amenable to radiotherapy with curative intent
Progressive disease after one of the following prior treatments for metastatic disease:
- Oxaliplatin-based chemotherapy
- Irinotecan and oxaliplatin combination chemotherapy
At least 1 measurable lesion
- At least 20 mm in at least one dimension
- No known CNS metastases or carcinomatous meningitis
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 0.5 mg/dL above upper limit of normal (ULN)
- AST no greater than 5 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No unstable angina
- No symptomatic congestive heart failure
- No serious uncontrolled cardiac arrhythmia
Other:
- No active or uncontrolled infection
- No evidence of other serious illness
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomas
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent sargramostim (GM-CSF)
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- No more than 1 prior chemotherapy regimen for advanced colorectal cancer
- Prior adjuvant chemotherapy allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to more than 25% of bone marrow
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior major surgery
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: irinotecan
Prior oxaliplatin-based chemotherapy: Patients receive irinotecan IV over 90 minutes on day 1. Treatment repeats every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a confirmed complete response for 2 consecutive courses may discontinue treatment at investigator's discretion. Quality of life is assessed at baseline, approximately every 6 weeks during treatment, and then after the last course of treatment. Patients are followed every 3 months for 5 years. |
|
Experimental: leucovorin + fluorouracil
Prior to irinotecan and oxaliplatin combination chemotherapy: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously on days 1 and 2. Treatment repeats every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a confirmed complete response for 2 consecutive courses may discontinue treatment at investigator's discretion. Quality of life is assessed at baseline, approximately every 6 weeks during treatment, and then after the last course of treatment. Patients are followed every 3 months for 5 years. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
tasa de respuesta tumoral
Periodo de tiempo: Hasta 5 años
|
Hasta 5 años
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
sobrevivencia promedio
Periodo de tiempo: Hasta 5 años
|
Hasta 5 años
|
calidad de vida
Periodo de tiempo: Hasta 5 años
|
Hasta 5 años
|
time to tumor progression
Periodo de tiempo: Up to 5 years
|
Up to 5 years
|
tiempo hasta el fracaso del tratamiento
Periodo de tiempo: Hasta 5 años
|
Hasta 5 años
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Henry C. Pitot, MD, Mayo Clinic
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 del Colon
- Enfermedades intestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Neoplasias colorrectales
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes Protectores
- Inhibidores de la topoisomerasa
- Micronutrientes
- Vitaminas
- Hormonas y agentes reguladores del calcio
- Inhibidores de la topoisomerasa I
- Antídotos
- Complejo de vitamina B
- Fluorouracilo
- Leucovorina
- Irinotecán
- Calcio
- Levoleucovorina
Otros números de identificación del estudio
- NCCTG-N0048
- NCI-2012-02383 (Identificador de registro: CTRP (Clinical Trials Reporting System))
- CDR0000068635 (Identificador de registro: PDQ (Physician Data Query))
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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