- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00085280
Erlotinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
A Pilot Study to Determine if Downstream Markers of EGFR Linked Signaling Pathways Predict Response to OSI-774 (Erlotinib) in the First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
I. Prospectively identify downstream markers of EGFR linked signaling pathways that are predictive of response to OSI-774 (Erlotinib) in this population.
SECONDARY OBJECTIVES:
I. Estimate antitumor objective response rate per RECIST. II. Estimate disease control rate (CR+PR+SD). III. Estimate time to progression and overall survival. IV. Estimate if a grade 2 rash is a predictor of response to OSI-774 (Erlotinib) and of patient survival.
V. Assess safety profile of OSI-774 (Erlotinib) in this population. VI. To determine whether smoking status is linked to outcome for advanced NSCLC patients treated with OSI-774 (Erlotinib).
OUTLINE: This is a pilot, multicenter study.
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients complete the Smoking Status Survey, a questionnaire regarding smoking habits, at baseline, and then every 3 months during study treatment.
After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 129 patients will be accrued for this study within 6 months.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02215
- Eastern Cooperative Oncology Group
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients must have pathologically confirmed NSCLC
- Patients must have diagnostic specimen available on paraffin-embedded block
- Patients must have advanced NSCLC (stage IIIB with a malignant pleural effusion or IV disease, or recurrent disease)
Patients must not have received prior chemotherapy or targeted therapy for metastatic disease, including no prior EGFR inhibitor; patient may have received adjuvant chemotherapy for early stage disease (IB-IIIA), or chemo/XRT for stage IIIA or IIIB disease, provided s/he meets all of the following:
- It has been at least 6 months since completion of patient's adjuvant chemotherapy for early stage disease (IB-IIIA) or chemo/XRT for stage IIIA or IIIB disease
- Patient now has advanced disease
- Patients must have measurable disease per RECIST criteria; all sites of disease must be assessed within 4 weeks prior to registration
- Creatinine < 1.5 mg/dL or a creatinine clearance of > 50 mL/min
- SGOT(AST) and SGPT(ALT) < 2 x the institution's upper limit of normal
- Bilirubin < 1.5 mg/dL
- ANC > 1500/mm^3
- PLT > 100,000/mm^3
- Patients must have ECOG performance status 0, 1, or 2
- Patients with stable, treated brain metastases are eligible (defined as: patients with brain metastases must have been treated and are asymptomatic and are no longer taking corticosteroids)
- Patients with gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease, are ineligible
- Pregnant and breast feeding women are excluded from the study because the agent 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
- Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) for the duration of the study
- HIV positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with OSI-774 (Erlotinib)
- Patients must not have had immuno, hormonal or radiation therapy within 2 weeks prior to entering the study; those who have not recovered from adverse events due to agents administered more than 2 weeks earlier are ineligible; previously irradiated areas can be considered "measurable disease" if there has been documented progression
- Patients must not have ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
- Patients must not have serious non-healing wound, or bone fracture, or major surgical procedure within 21 days prior to study entry
- Patients taking Warfarin are eligible
- If the patient is taking Cyp3A4 inducers or inhibitors, they must be discontinued one week prior to starting OSI-774 (Erlotinib)
- Patients must not be enrolled in any other concurrent clinical trials
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 (erlotinib hydrochloride)
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients complete the Smoking Status Survey, a questionnaire regarding smoking habits, at baseline, and then every 3 months during study treatment. |
Estudios correlativos
Administrado oralmente
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Response rates and distribution of the mitogen-activated protein kinase (MAPK)/extracellular-signal-regulated kinase (Erk)-phosphorylated expression groups based on the Response Evaluation Criteria in Solid Tumors (RECIST)
Periodo de tiempo: Up to 5 years
|
A Fisher's exact test with a two-sided 5% type I error rate will be calculated.
|
Up to 5 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Sobrevivencia promedio
Periodo de tiempo: Hasta 5 años
|
Hasta 5 años
|
|
Objective response rate based on the RECIST
Periodo de tiempo: Up to 5 years
|
Up to 5 years
|
|
Disease control rate (complete response [CR]+partial response [PR]+stable disease [SD])
Periodo de tiempo: Up to 8 weeks
|
Up to 8 weeks
|
|
Time to progression
Periodo de tiempo: Date of entry on the study to the appearance of new metastatic lesions or objective tumor progression, up to 5 years
|
Date of entry on the study to the appearance of new metastatic lesions or objective tumor progression, up to 5 years
|
|
Toxicities associated with erlotinib hydrochloride, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
Periodo de tiempo: Up to 5 years
|
Up to 5 years
|
|
Relationship between clinical response and each of the markers using the semiquantitative histo-score method
Periodo de tiempo: Baseline
|
Cox regression models will be used.
|
Baseline
|
Effects of smoking status in terms of disease and survival
Periodo de tiempo: Up to 5 years
|
Descriptive and summary statistics will be conducted on the smoking questionnaire data.
|
Up to 5 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Julie Brahmer, Eastern Cooperative Oncology Group
Publicaciones y enlaces útiles
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 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
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la proteína quinasa
- Clorhidrato de erlotinib
Otros números de identificación del estudio
- NCI-2012-03147 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- U10CA021115 (Subvención/contrato del NIH de EE. UU.)
- CDR0000368459
- ECOG-E3503
- E3503 (Otro identificador: CTEP)
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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