- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00063947
Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer
A Phase I Study of OSI-774 in Combination With Gemcitabine and Radiation in Locally Advanced, Non-Operable Pancreatic Cancer
Descripción general del estudio
Estado
Condiciones
Descripción detallada
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of erlotinib given concurrently with gemcitabine and radiotherapy in patients with locally advanced unresectable pancreatic cancer.
SECONDARY OBJECTIVES:
I. Determine the toxicity of this regimen in these patients. II. Determine, preliminarily, the antitumor efficacy of this regimen, in terms of response rate, in these patients.
III. Determine the time to tumor progression and overall survival of patients treated with this regimen.
OUTLINE: This is a non-randomized, open-label, dose-escalation study of erlotinib.
Chemoradiotherapy: Patients undergo radiotherapy 5 days a week for 5.5 weeks. Beginning on day 1 and continuing concurrently with radiotherapy, patients receive gemcitabine IV over 30 minutes twice weekly and oral erlotinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients receive treatment at that dose.
Patients are radiologically restaged 3-4 weeks after completion of radiotherapy. Patients with stable or responsive disease proceed to maintenance therapy. Patients whose imaging studies suggest a potential for curative resection are referred for a surgical evaluation before initiating maintenance therapy.
Maintenance therapy: Beginning 4-7 weeks after the completion of chemoradiotherapy, patients receive maintenance chemotherapy comprising gemcitabine IV over 30 minutes on days 1 and 8 and oral erlotinib once daily. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 19-28 patients will be accrued for this study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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-
New York
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New York, New York, Estados Unidos, 10065
- Memorial Sloan-Kettering Cancer Center
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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:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
Locally advanced, unresectable disease, defined by all of the following:
- Obvious encasement of the celiac, hepatic, or superior mesenteric artery
- Encasement of the portal or superior mesenteric vein not amenable to surgical resection
- Extrapancreatic extension with or without regional lymph node involvement
- No evidence of distant metastatic disease by staging laparoscopy*
Locally recurrent disease after prior curative surgery allowed provided the following are true:
- No prior chemotherapy or radiotherapy
- No evidence of distant metastatic disease by staging laparoscopy*
- No islet cell pancreatic cancer or lymphoma or sarcoma of the pancreas
Measurable or evaluable disease
- Primary pancreatic tumor is considered evaluable and not measurable disease
- Lymph node mass considered measurable disease
- No known brain metastases
- Performance status - ECOG 0-2
- More than 12 weeks
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine ≤ 2.0 mg/dL
- Creatinine clearance ≥ 60 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No abnormalities of the cornea based on history (e.g., dry eye syndrome or Sjögren's syndrome)
- No congenital abnormality (e.g., Fuch's dystrophy)
- No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
- No abnormal corneal sensitivity test (Schirmer test or similar tear production test)
- No Crohn's disease or inflammatory bowel disease that would preclude undergoing external beam radiotherapy
- Able to tolerate oral medication
- No requirement for IV alimentation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No ongoing or active infection
- No other concurrent uncontrolled illness
- No psychiatric illness or social situation that would preclude study compliance
- See Disease Characteristics
- No prior gemcitabine
- See Disease Characteristics
- See Disease Characteristics
- No prior epidermal growth factor receptor-targeting therapy
- No prior therapy for pancreatic cancer (except surgery)
- No concurrent commercial or other investigational agents or therapies intended to treat the malignancy
- No concurrent combination antiretroviral therapy for HIV-positive patients
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: Treatment (radiotherapy, gemcitabine, erlotinib hydrochloride)
Chemoradiotherapy: Patients undergo radiotherapy 5 days a week for 5.5 weeks.
Beginning on day 1 and continuing concurrently with radiotherapy, patients receive gemcitabine IV over 30 minutes twice weekly and oral erlotinib once daily.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients with stable or responsive disease proceed to maintenance therapy.
Maintenance therapy: Beginning 4-7 weeks after the completion of chemoradiotherapy, patients receive maintenance chemotherapy comprising gemcitabine IV over 30 minutes on days 1 and 8 and oral erlotinib once daily.
Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
|
Estudios correlativos
Dado IV
Otros nombres:
Someterse a radioterapia
Otros nombres:
Administrado oralmente
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Maximum-tolerated dose (MTD) of erlotinib hydrochloride based on the incidence of dose-limiting toxicity (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Periodo de tiempo: 7.5 weeks
|
7.5 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Toxicity as assessed by CTCAE version 3.0
Periodo de tiempo: 7.5 weeks
|
7.5 weeks
|
|
Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)
Periodo de tiempo: Up to 6 years
|
Kaplan-Meier methods will be utilized to estimate the response duration.
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Up to 6 years
|
Progression-free survival as assessed by RECIST
Periodo de tiempo: From the time of study enrollment until progression of disease is documented, assessed up to 6 years
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Kaplan-Meier methods will be utilized to estimate the progression-free survival.
|
From the time of study enrollment until progression of disease is documented, assessed up to 6 years
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Overall survival
Periodo de tiempo: From the time of study enrollment until the date of death, assessed up to 6 years
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From the time of study enrollment until the date of death, assessed up to 6 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Eileen O'Reilly, Memorial Sloan Kettering Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (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
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias
- Neoplasias por sitio
- Enfermedades del sistema endocrino
- Neoplasias del Sistema Digestivo
- Neoplasias de glándulas endocrinas
- Enfermedades pancreáticas
- Neoplasias pancreáticas
- 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
- Inhibidores de la proteína quinasa
- Gemcitabina
- Clorhidrato de erlotinib
Otros números de identificación del estudio
- NCI-2012-01439
- U01CA069856 (Subvención/contrato del NIH de EE. UU.)
- 03-031
- NCI-5441
- CDR0000305855
- MSKCC-03031
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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