- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02775006
Docetaxel Versus Intercalated Erlotinib-docetaxel in Patients With Relapsed EGFR Wild Type, ALK Negative Non Squamous Cell Carcinoma
A Randomized Phase III Study of Docetaxel Versus Intercalated Erlotinib Docetaxel Combination Therapy in Patients With Relapsed EGFR (Epidermal Growth Factor Receptor) Wild Type, ALK(Anaplastic Lymphoma Kinase) Negative Non Squamous Cell Carcinoma. (NVALT 18 Study)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The aim of this study is to investigate the effect of docetaxel monotherapy and the combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type, ALK negative non squamous cell carcinoma.
As pemetrexed is standard first line treatment, the combination of erlotinib docetaxel in non-squamous NSCLC should be investigated as second line treatment. Also the question has to be answered whether the combination outperforms monotherapy treatments.
After stratification for ECOG-performance status (0-1), response to prior treatment (CR, PR, SD versus PD), treatment free interval after platinum based therapy (<6 months versus >6 months) and maintenance, patients will be centrally randomized to receive either docetaxel (arm A) or docetaxel plus erlotinib (arm B).
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Apeldoorn, Países Bajos
- Gelre Ziekenhuis
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Breda, Países Bajos
- Amphia Hospital
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Den Bosch, Países Bajos
- Jeroen Bosch Hospital
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Den Haag, Países Bajos, 2545 CH
- Haga
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Dordrecht, Países Bajos
- Albert Schweitzer Ziekenhuis
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Ede, Países Bajos
- Ziekenhuis Gelderse Vallei
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Eindhoven, Países Bajos, 5631 BM
- Maxima Medisch Centrum
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Groningen, Países Bajos
- Martini Ziekenhuis
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Hoofddorp, Países Bajos, 2130 AT
- Spaarne Gasthuis
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Leeuwarden, Países Bajos, 8934 AD
- MCL
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Maastricht, Países Bajos
- Maastricht University Medical Center
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Roermond, Países Bajos
- Laurentius Hospital
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Rotterdam, Países Bajos
- Erasmus MC
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Rotterdam, Países Bajos, 3045 PM
- St. Fransicus Gasthuis
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Rotterdam, Países Bajos, 3083 AN
- Ikazia
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Utrecht, Países Bajos
- St. Antonius Ziekenhuis
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Venlo, Países Bajos
- VieCuri Medisch Centrum voor Noord-Limburg
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the Hague, Países Bajos
- Medical Center Haaglanden
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Noord-Holland
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Amsterdam, Noord-Holland, Países Bajos, 1081HV
- VUmc Medical Center
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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:
- Histologically or cytologically confirmed EGFR wild type, ALK negative, non-squamous cell carcinoma, locally advanced and metastatic disease stage IIIB and IV. Evidence of disease progression after one cytotoxic treatment platinum containing regimen. Immunotherapy pretreatment is allowed
- Complete recovery from prior chemotherapy side effects to < Grade 2.
- At least one unidimensionally measurable lesion meeting RECIST criteria.
- ECOG PS 0-1.
- Age ≥ 18 years.
Adequate organ function, including:
- Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets ≥ 100 x 109/L.
- Hepatic: bilirubin ≤1.5 x ULN (upper limit normal), AP, ALT, AST ≤ 1.5 x ULN. AP, ALT, and AST ≤5 x ULN is acceptable if the liver has tumor involvement.
- Renal: calculated creatinine clearance ≥ 40 ml/min based on the Cockcroft-Gault formula.
- Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
- Signed informed consent.
- Patient compliance and geographical proximity that allow adequate follow up.
- Patients who have undergone cranial irradiation for brain metastases more than 4 weeks before inclusion in our protocol, provided that they are clinically fit to undergo second line treatment
Exclusion Criteria:
- Pregnant or lactating women.
- Patients with medical risks because of non-malignant disease as well as those with active uncontrolled infection.
- Documented brain metastases unless the patient has completed local therapy for central nervous system metastases at least 4 weeks before enrollment and has been off corticosteroids for at least two weeks before enrollment. Prophylactic irradiation at least 4 weeks prior to enrollment is accepted.
- Maintenance treatment with erlotinib or other TKI (Tyrosine Kinase Inhibitor), or docetaxel. Maintenance treatment with pemetrexed is allowed. Previous treatment with an EGFR-TKI or docetaxel within 6 months prior to enrollment.
- Inability or unwillingness to take dexamethasone.
- Concomitant treatment with any other experimental drug under investigation.
- Patients experiencing disease progression within 2 months after the start of platinum based chemotherapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Docetaxel
Docetaxel 75mg/m2 every 21 days until disease progression or toxicity related
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75mg/m2
Otros nombres:
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Comparador activo: Docetaxel plus erlotinib
Docetaxel 75mg/m2 on Day 1 plus erlotinib 150mg/day days 2-16, every 21 days, until disease progression, or toxicity related.
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75mg/m2
Otros nombres:
150mg/day
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
progression free survival
Periodo de tiempo: from the date of randomization to the first date of progression of disease or of death from any cause up to 24 months after last treatment administration
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from the date of randomization to the first date of progression of disease or of death from any cause up to 24 months after last treatment administration
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
quantitative and qualitative adverse events
Periodo de tiempo: from the date of randomization until resolution or stabilization of the event and up to 30 days after the last study medication/treatment
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Adverse events will be graded according to NCI Common Toxicity Criteria version 4.03
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from the date of randomization until resolution or stabilization of the event and up to 30 days after the last study medication/treatment
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response rates
Periodo de tiempo: Every six weeks from date of randomization until the date of first documented progression or date of death from any cause up to 24 months after last treatment administration
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Every six weeks from date of randomization until the date of first documented progression or date of death from any cause up to 24 months after last treatment administration
|
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duration of response
Periodo de tiempo: from the date of the first objective status assessment of a complete or partial response to the first date of progression of disease or death from any cause up to 24 months after last treatment administration
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from the date of the first objective status assessment of a complete or partial response to the first date of progression of disease or death from any cause up to 24 months after last treatment administration
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overall survival
Periodo de tiempo: from the date of randomization to the date of death from any cause up to 24 months after last treatment administration
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Evaluation of overall survival (OS)
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from the date of randomization to the date of death from any cause up to 24 months after last treatment administration
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Erlotinib dose level variance in blood
Periodo de tiempo: Every six weeks from randomisation up until last treatment administration (up until 48 weeks)
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Therefore in patients on erlotinib every 6 weeks through dose levels in blood will be determined
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Every six weeks from randomisation up until last treatment administration (up until 48 weeks)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Joachim G Aerts, MD PhD, Dutch Society of Physicians for Pulmonology and Tuberculosis
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
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Neoplasias por tipo histológico
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Neoplasias Glandulares y Epiteliales
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- Carcinoma
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Inhibidores de la proteína quinasa
- Docetaxel
- Clorhidrato de erlotinib
Otros números de identificación del estudio
- NVALT 18
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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