- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00020189
Flavopiridol in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
A Phase II Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent or metastatic head and neck cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Determine the standard response rate (complete response and partial response) and duration of response in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with flavopiridol.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the effects of anti-platelet agents, aspirin and clopidogrel bisulfate, on the pharmacology of flavopiridol in these patients.
- Determine the effects of prophylactic anticoagulation with anti-platelet agents, aspirin and clopidogrel bisulfate, on the incidence of flavopiridol-related thrombosis in these patients.
OUTLINE: Patients receive flavopiridol IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients also receive oral aspirin and clopidogrel bisulfate beginning on day 0 and continuing throughout the study.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 1-3 years.
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Bethesda, Maryland, Estados Unidos, 20892
- Center for Cancer Research
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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:
Histologically proven squamous cell carcinoma of the head and neck
- Metastatic disease at diagnosis OR
- Persistent, metastatic, or recurrent disease after prior definitive surgery and/or radiotherapy
- No undifferentiated and nonkeratinizing carcinomas, including lymphoepitheliomas of all locations
- No nasopharynx tumors
Bidimensionally measurable disease
- Patients whose only measurable disease is within a prior radiotherapy port must have clearly progressive disease
- No metastatic or leptomeningeal CNS disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count greater than 100,000/mm^3
- Absolute granulocyte count greater than 1,500/mm^3
Hepatic:
- See Other (Prior/Concurrent Therapy)
- SGOT and SGPT less than 2.5 times normal
- Bilirubin less than 1.5 times normal
- No history of hypercoagulopathies (e.g., protein C deficiency, protein S deficiency, or lupus anticoagulant)
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
- Calcium no greater than normal
- No hypercalcemia refractory to bisphosphonates
Cardiovascular:
- No unstable or newly diagnosed angina pectoris
- No myocardial infarction within the past 6 months
- No class II-IV congestive heart failure
- No history of symptomatic carotid disease
- No concurrent asymptomatic carotid artery occlusion (70% or greater) in one or both arteries by Doppler ultrasound
- No symptomatic atherosclerosis
- No thrombotic events within the past 6 months
Pulmonary:
- No aspirin-induced asthma
Other:
- No inability to take aspirin or clopidogrel bisulfate due to contraindications, allergies, or pre-existing medical conditions (e.g., active peptic ulcer disease or history of undiagnosed non-occult, non-hemorrhoidal gastrointestinal or other bleeding sources within the past 6 months)
- No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in complete remission
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent biologic therapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy and recovered
- No prior flavopiridol
- No more than 3 prior systemic chemotherapy regimens for recurrent or metastatic disease
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy except oral contraceptives
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior surgery and recovered
- No prior carotid endarterectomy or other revascularization surgery
Other:
- No other concurrent antineoplastic therapies
- No active anticoagulation with INR 1.5 or greater
- No low-molecular weight heparin or equivalent
- Concurrent bisphosphonates for calcium maintenance allowed
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Barbara A. Conley, MD, National Cancer Institute (NCI)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
- cáncer de cuello escamoso metastásico no tratado con tumor primario oculto
- Cáncer de cuello escamoso metastásico recurrente con tumor primario oculto
- cáncer de cuello escamoso metastásico con carcinoma de células escamosas primario oculto
- Carcinoma de células escamosas de labio y cavidad oral en estadio IV
- Carcinoma recurrente de células escamosas de labio y cavidad oral.
- Carcinoma de células escamosas de la orofaringe en estadio IV
- carcinoma de células escamosas recurrente de la orofaringe
- Carcinoma de células escamosas de hipofaringe en estadio IV
- carcinoma de células escamosas recurrente de hipofaringe
- Carcinoma de células escamosas de laringe en estadio IV
- carcinoma de células escamosas recurrente de laringe
- Carcinoma de células escamosas en estadio IV del seno paranasal y la cavidad nasal
- Carcinoma de células escamosas recurrente del seno paranasal y la cavidad nasal
- cáncer de glándulas salivales recurrente
- cáncer de glándulas salivales en estadio IV
- tromboembolismo
- carcinoma de células escamosas de las glándulas salivales
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Neoplasias
- Neoplasias por sitio
- Embolia y Trombosis
- Neoplasias de Cabeza y Cuello
- Tromboembolismo
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes del sistema nervioso periférico
- Inhibidores de enzimas
- Analgésicos
- Agentes del sistema sensorial
- Agentes antiinflamatorios no esteroideos
- Analgésicos no narcóticos
- Agentes antiinflamatorios
- Agentes antirreumáticos
- Agentes fibrinolíticos
- Agentes moduladores de fibrina
- Inhibidores de la agregación plaquetaria
- Inhibidores de la ciclooxigenasa
- Antipiréticos
- Antagonistas del receptor P2Y purinérgico
- Antagonistas del receptor P2 purinérgico
- Antagonistas purinérgicos
- Agentes Purinérgicos
- Agentes antineoplásicos
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Inhibidores de la proteína quinasa
- Aspirina
- Clopidogrel
- Alvocidib
Otros números de identificación del estudio
- CDR0000068028
- NCI-00-C-0128
- MB-401
- NCI-T99-0066
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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