Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer
A Phase II Study of Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer
Descripción general del estudio
Descripción detallada
Rationale: Patients with advanced stage head and neck cancer, especially those with disease in the hypopharynx, oropharynx, or oral cavity, and poor performance status defined through clinical testing, are often not eligible for clinical trials and treated with best supportive care. The possibility of developing a well-tolerated chemotherapy regimen in these patients may lead to an equivalent benefit and better palliation. The current study offers the chemotherapy drug pemetrexed to patients with advanced head and neck cancer. Researchers consider this agent to have some anti-tumor efficacy against a variety of site-specific cancers, including head and neck cancer with a response rate that is similar to other single chemotherapy drugs. In addition, previous research indicates that toxicities associated with pemetrexed have been reduced when patients are given folic acid and B12 vitamin supplementation. Along with pemetrexed, the current study provides study participants with both folic acid and B12.
Purpose: The primary objective of this study is to evaluate tumor response, including complete and partial remission, and toxicities from pemetrexed in patients with advanced head and neck cancer. Secondary objectives of this study include measurements of time to tumor progression, survival, and patient quality of life.
Treatment: Study participants will be given pemetrexed through intravenous infusions. Pemetrexed will be administered once every three weeks. This schedule of pemetrexed once every three weeks will be repeated up to six times. Study participants will also be provided with both folic acid and B12 vitamin supplementation before, during, and after study treatments with pemetrexed. Vitamin supplementation is considered critical and compliance must be followed closely. Several tests and exams will be given throughout the study to monitor patients. Treatments will be discontinued due to disease growth and unacceptable side effects.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Ohio State University
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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:
- Advanced, metastatic, or recurrent head and neck cancers
- Poor risk patients with ECOG performance status of 2
Exclusion Criteria:
- Prior treatment for recurrent or metastatic disease
- No clinical or radiological evidence of brain metatases
- Patients with bone only disease are not eligible
- Patients with pleural or peritoneal effusion as only manifestation of diesase
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 |
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Experimental: Pemetrexed
pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
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500 mg/m2 IV every 3 weeks for 6 cycles
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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Overall Response Rate
Periodo de tiempo: Up to 3 years
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Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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Up to 3 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer
Periodo de tiempo: Up to 3 years
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Drug induced toxicities were assessed and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
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Up to 3 years
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Impact of Pemetrexed Chemotherapy on Quality of Life
Periodo de tiempo: Baseline, End of Treatment [up to 3 years]
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Quality of life assessements conducted at BL (baseline assessment) and EoT (End of treatment).
University of Washington QOL (UW-QOL) questionnaire tests 9 specific areas relating to head and neck cancer.
A composite score is calculated by adding together the 9 domain scores to give a scale from 0 (for poor health) to 900 (good health).
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Baseline, End of Treatment [up to 3 years]
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Overall Survival
Periodo de tiempo: Up to 2 years
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Overall survival was measured from the time of initial study entry to death due to any cause.
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Up to 2 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anterpreet Neki, M.D., Ohio State University
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
Otros números de identificación del estudio
- OSU-0482
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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Ensayos clínicos sobre Pemetrexed
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Northwestern UniversityNational Cancer Institute (NCI)DesconocidoLinfoma | Tumores cerebrales y del sistema nervioso central | Cáncer metastásicoEstados Unidos
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Rongjie TaoNational Natural Science Foundation of ChinaDesconocidoMetástasis cerebralesPorcelana
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PfizerTerminadoCarcinoma de pulmón de células no pequeñasEstados Unidos, Alemania, Italia
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Norwegian University of Science and TechnologySt. Olavs HospitalTerminadoCarcinoma de pulmón de células no pequeñasNoruega
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Ain Shams UniversityDesconocido
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Spanish Lung Cancer GroupTerminadoCarcinoma De Pulmón De Células No PequeñasEspaña
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Eli Lilly and CompanyTerminadoCáncer de pulmón de células no pequeñas metastásico | Neoplasia de pulmón de células no pequeñas no escamosas | Cáncer de pulmón de células no pequeñas en estadio IIIBReino Unido, Suecia