- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00217282
Study of Oxaliplatin and Gemcitabine With or Without Bevacizumab to Treat Advanced Non-Small Cell Lung Cancer
Phase II Trial OF Oxaliplatin and Gemcitabine With Bevacizumab in Advanced Non-Small Cell Lung Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
STUDY OBJECTIVES:
Primary:
To determine the overall time to progression of the combination regimen of Gemcitabine, Oxaliplatin and Bevacizumab as first-line treatment in patients with Stage IIIB and IV non-small cell lung cancer.
Secondary
- To determine the overall response rate
- To determine the overall survival.
- To determine the toxicity of Gemcitabine, Oxaliplatin given in combination with Bevacizumab
ELIGIBILITY CRITERIA
- Patients must have histologically or cytologically confirmed non-small cell lung cancer EXCEPT squamous cell carcinoma. Mixed tumors will be categorized by the predominant cell type unless small cell elements are present in which case the patient is ineligible. Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy.
- Patients must have advanced NSCLC (Stage IIIB with malignant pleural effusion or Stage IV or recurrent disease).
- Patients must have measurable disease (as defined in Section 13.0).
- ECOG performance status 0 or 1.
- Patients must not have known CNS metastases. Brain imaging is required within 4 weeks prior to study entry.
- No prior systemic treatment for advanced NSCLC is permitted. Prior treatment for early-stage disease (adjuvant) or for locally-advanced Stage III disease is allowed if completed at least 12 months prior to registration.
Required laboratory values (obtained 2 weeks prior to registration):
7.1 ANC > 1500/mm³. 7.2 Platelets > 100,000/mm³. 7.3 Total Bilirubin < 1.5 mg/dl. 7.4 Transaminases < 5 x ULN.
Patients must have adequate renal function as determined by the following tests within 2 weeks prior to registration.
8.1 Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN), AND Urinalysis < 1+ protein*
* Patients discovered to have >1+ proteinuria at baseline must undergo a 24-hour urine collection. This must be an adequate collection and must demonstrate <1g of protein/24 hr to allow participation in the study.
- Patients must be 18 years or older.
- Pregnant and lactating women are excluded from the study because the agents used in this study may be teratogenic to a fetus and there is no information on the excretion of the agents or their metabolites into breast milk. A negative urine or serum pregnancy test required for women of childbearing potential.
- Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study.
- Patients treated with radiation therapy must have adverse events from therapy resolved to grade 2 or less following completion of treatment.
- Patients must not have ongoing or active infection, symptomatic congestive heart failure, cerebrovascular accident within 12 months, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients must have no deep vein thrombosis or pulmonary embolus within one year of registration and no ongoing need for full-dose oral or parenteral anticoagulation. Low dose coumadin (1mg) for maintenance of catheter patency or daily prophylactic aspirin is allowed.
- Patients with history of hypertension must be well-controlled (defined as a blood pressure of >160 mmHg systolic and/or > 110 mmHg diastolic) on a stable regimen of anti-hypertensive therapy.
- Patients must not have serious non-healing wound ulcer, or bone fracture, or major surgical procedure within 3 weeks prior to starting treatment.
- Patients with a history of gross hemoptysis (defined as bright red blood of a ½ teaspoon or more) will be excluded from this trial
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years
TREATMENT PLAN Gemcitabine 1000mg/m2 IV over 30 minutes, on days 1 and 8 followed by Oxaliplatin 130mg/m2 IV over 2 hours on day 1 followed by Bevacizumab 15 mg/kg IV over 90* minutes, on day 1 Cycles q 3 weeks x 4 cycles One cycle equals 3 weeks. Patients will be re-evaluated every 2 cycles. If CR, PR or SD, patients will continue treatment up to four cycles or until progression or unacceptable toxicity.
Patients achieving CR, PR, or SD after 4 cycles will continue Bevacizumab maintenance:
Bevacizumab 15 mg/kg IV q 3 weeks until relapse/progression
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Florida
-
Miami Beach, Florida, Estados Unidos, 33140
- Mount Sinai Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Confirmed non-small cell lung cancer, EXCEPT squamous cell cancer
- Stage IIIB or IV disease
- ECOG PS 0-1
- No prior treatment
- No brain metastases
- Must have measurable disease
Exclusion Criteria:
- Deep vein thromboses or pulmonary embolus within 1 year
- History of gross hemoptysis
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
To determine the overall time to progression of the combination regimen of Gemcitabine, Oxaliplatin and Bevacizumab as first-line treatment in patients with Stage IIIB and IV non-small cell lung cancer.
Periodo de tiempo: Prospective
|
Prospective
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
• To determine the overall response rate • To determine the overall survival. • To determine the toxicity of Gemcitabine, Oxaliplatin given in combination with Bevacizumab
Periodo de tiempo: Prospective
|
Prospective
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rogerio Lilenbaum, Icahn School of Medicine at Mount Sinai
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
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- 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
- Agentes antineoplásicos inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Gemcitabina
- Oxaliplatino
- Bevacizumab
Otros números de identificación del estudio
- LUN08
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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