Phase I/II Study of Chemoprevention With EGFR and COX-2 Inhibitor
21 de octubre de 2014 actualizado por: Dong Shin, Emory University
Phase I/II Study of Chemoprevention With Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva) and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib) in Premalignant Lesions of Head and Neck of Former Smokers
Evaluate effect on cells and patient response to study medications, assess side effects of these medications, and evaluate chemicals in cells that may tell how the drug works, before, and after receiving the study medications.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The purpose of this study is to evaluate the effect on cells and patient response to study medications, assess the side effects of these medications, and to evaluate chemicals in the cells that may tell how the drug works, before, and after receiving the study medications.
Approximately 61 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital in Atlanta, Georgia.
Tipo de estudio
Intervencionista
Inscripción (Actual)
17
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University Winship Cancer Institute
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Participants must have premalignant lesions.
- Lesion sites include oral cavity, oropharynx, and larynx.
- Must have at least a >20 pack-year history of smoking.
- Must have a Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-1.
- Participants must be 18 years of age or older.
- No contraindications for laryngoscopy and biopsy.
- Adequate liver function.
- Must have hemoglobin and hematocrit levels at or above the lower limit of the normal range.
- Participants must have prothrombin time (PT)/partial thromboplastin time (PTT) levels at or above the lower limit of the normal range.
- Women of child-bearing potential must have a negative serum pregnancy test within 72 hours of receiving treatment.
- Must be able to swallow the oral dose of erlotinib and celecoxib.
- Participants must be disease free.
- Final eligibility will be determined by the health professionals conducting the trial.
Exclusion Criteria:
- Participants with acute intercurrent illness or those who had surgery within the preceding 4 weeks unless they have fully recovered.
- History of previous malignancies unless the cancer was stage I or II and rendered free of disease more than 1 year.
- Pregnant or breast feeding.
- Not practicing adequate contraception if the participants are of child bearing potential.
- Female patients who have a positive pregnancy test.
- History or recent myocardial infarction.
- Hypertension not adequately controlled by medication.
- Documented history of coagulopathy.
- Documented history of congestive heart failure (CHF) greater than New York Heart Association (NYHA) Grade II.
- Participants who were taking COX-2 inhibitors or EGFR tyrosine kinase inhibitors within 3 months of study entry.
- Documented history or interstitial lung disease.
- Known connective tissue disease.
- History of nonsteroidal antiinflammatory drug (NSAID)-induced ulcers or those who are at risk for a GI ulcer.
- Participated in a clinical trial of an investigational drug within 12 months prior to enrollment.
- Final eligibility will be determined by the health professionals conducting the trial.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Erlotinib & Celecoxib
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Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion. Celecoxib given 400 mg orally BID continuously for 6 months.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Dose Escalation and Toxicity: Toxicities Including Grades 1 to 4
Periodo de tiempo: 12 months from time of enrollment
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Participants received a fixed dose of celecoxib 400 mg orally BID continuously for 6 months.
Erlotinib was dose escalated at 3 dose levels of 50, 75, and 100 mg orally every day for 6 months.
Dose escalation followed a standard 3+3 escalation design.
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12 months from time of enrollment
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Clinical Outcome: Documented Progression
Periodo de tiempo: 12 months from time of enrollment
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Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist.
Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium.
Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia).
Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment.
Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment.
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12 months from time of enrollment
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Clinical Outcome: Progression to a Higher-grade Dysplasia or Carcinoma
Periodo de tiempo: Up to 55 months from initiation of therapy. Median duration of follow-up was 36 months.
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Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist.
Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium.
Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia).
Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment.
Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment.
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Up to 55 months from initiation of therapy. Median duration of follow-up was 36 months.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dong Shin, MD, Emory University Winship Cancer Institute
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Shin DM, Zhang H, Saba NF, Chen AY, Nannapaneni S, Amin AR, Muller S, Lewis M, Sica G, Kono S, Brandes JC, Grist WJ, Moreno-Williams R, Beitler JJ, Thomas SM, Chen Z, Shin HJ, Grandis JR, Khuri FR, Chen ZG. Chemoprevention of head and neck cancer by simultaneous blocking of epidermal growth factor receptor and cyclooxygenase-2 signaling pathways: preclinical and clinical studies. Clin Cancer Res. 2013 Mar 1;19(5):1244-56. doi: 10.1158/1078-0432.CCR-12-3149. Epub 2013 Feb 19.
- Saba NF, Hurwitz SJ, Kono SA, Yang CS, Zhao Y, Chen Z, Sica G, Muller S, Moreno-Williams R, Lewis M, Grist W, Chen AY, Moore CE, Owonikoko TK, Ramalingam S, Beitler JJ, Nannapaneni S, Shin HJ, Grandis JR, Khuri FR, Chen ZG, Shin DM. Chemoprevention of head and neck cancer with celecoxib and erlotinib: results of a phase ib and pharmacokinetic study. Cancer Prev Res (Phila). 2014 Mar;7(3):283-91. doi: 10.1158/1940-6207.CAPR-13-0215. Epub 2013 Oct 3.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2006
Finalización primaria (Actual)
1 de noviembre de 2012
Finalización del estudio (Actual)
1 de noviembre de 2012
Fechas de registro del estudio
Enviado por primera vez
11 de abril de 2006
Primero enviado que cumplió con los criterios de control de calidad
11 de abril de 2006
Publicado por primera vez (Estimar)
13 de abril de 2006
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
24 de octubre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
21 de octubre de 2014
Última verificación
1 de octubre de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias
- Condiciones precancerosas
- Efectos fisiológicos de las drogas
- 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
- Inhibidores de la ciclooxigenasa
- Agentes antineoplásicos
- Inhibidores de la proteína quinasa
- Inhibidores de la ciclooxigenasa 2
- Clorhidrato de erlotinib
- Celecoxib
Otros números de identificación del estudio
- IRB00024922
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. .