- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00063401
Phase II Study in Patients With Epidermal Growth Factor Receptor (EGFR) + Advanced Stage Ovarian, Primary Peritoneal and Fallopian Tube Cancer
7 de abril de 2010 actualizado por: Eli Lilly and Company
A Phase II Study of Cetuximab (C225)/Paclitaxel/Carboplatin for the Initial Treatment of Advanced Stage Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
The purpose of this study is to determine the progression-free survival obtained with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
The population being studied in this trial is subjects with advanced stage ovarian, primary peritoneal and fallopian tube cancer will be enrolled.
By receiving combination therapy with cetuximab (C225)/paclitaxel/carboplatin, these subjects will experience longer progression-free survival than previously reported for subjects receiving only paclitaxel and carboplatin.
Tipo de estudio
Intervencionista
Inscripción (Actual)
39
Fase
- Fase 2
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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New York
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New York, New York, Estados Unidos, 10021
- ImClone Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- ImClone Investigational Site
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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 y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria
- Subjects must have signed an approved informed consent.
- Subjects with histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma, Stage III or IV, with either optimal (≤ 1 cm residual disease) or suboptimal residual disease following initial surgery. All subjects must have had appropriate surgery for ovarian, primary peritoneal, or fallopian tube carcinoma with appropriate tissue available for histologic evaluation. Pathology must be verified at the participating institution
- Subjects with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.
- Subjects with tumor tissue available for assessment of EGFR status by IHC.
- EGFR expression must be positive (e.g., 1+).
- Subjects must have a Karnofsky Performance Status (KPS) of ≥ 70%.
- Subjects must be entered no more than 12 weeks postoperatively.
- Women, ages 18 and older.
- Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/ul, equivalent to Common Toxicity Criteria (CTC) grade 1. Platelets ≥ the institutional lower limit of normal (LLN), CTC grade 0.
- Renal function: creatinine ≤ 1.5 x institutional upper limit of normal (ULN), CTC grade 1.
- Hepatic function: bilirubin ≤ 1.5 x ULN, CTC grade 1. AST ≤ 2.5 x ULN, CTC grade 1.
- Neurologic function: neuropathy (sensory) ≤ CTC grade 1.
Exclusion Criteria
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
- WOCBP using a prohibited contraceptive method.
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- Subjects with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible. Subjects with a prior diagnosis of a low malignant potential tumor that was surgically resected and who subsequently develop invasive adenocarcinoma are eligible, provided that they have not received prior chemotherapy for any ovarian tumor.
- Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 3 years prior to registration, and the subject remains free of recurrent or metastatic disease.
- Subjects who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Subjects may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 3 years prior to registration,and that the subject remains free of recurrent or metastatic disease.
- With the exception of non-melanoma skin cancer and other specific malignancies as noted above, subjects with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded.
- Subjects with acute hepatitis.
- Subjects with active or uncontrolled infection are not eligible.
- Subjects with a significant history of cardiac disease, i.e., uncontrolled hypertension,unstable angina, and congestive heart failure.
- Subjects with left ventricular ejection fraction (LVEF) below the institutional range of normal on a baseline multiple gated acquisition (MUGA) scan or echocardiogram.
- A history of prior cetuximab or other therapy which targets the EGFR pathway or a history of prior chimerized or murine monoclonal antibody therapy.
- Subjects with a known allergy to murine proteins or Cremophor EL.
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: Tratamiento
- Asignación: No aleatorizado
- 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: 1
Cetuximab 400 mg/m2 IV (over 120 minutes) on Day 1 of Cycle 1, followed by weekly maintenance doses of 250 mg/m2 IV (over 60 minutes).
Paclitaxel 175 mg/m2 IC (over 3 hours) and carboplatin AUC of 6 IV (over 30 minutes) on Day 1 of each cycle.
For eligible subjects, maintenance therapy will consist of cetuximab 250 mg/m2/week for up to 6 months.
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400 mg/m2 loading dose, 250 mg/m2 weekly, six 21-day cycles
Otros nombres:
175 mg/m2 Day 1, six 21-day cycles
AUC = 6 Day1, six 21-day cycles
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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To determine the progression-free survival obtained with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer.
Periodo de tiempo: How long patients have progression-free survival
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How long patients have progression-free survival
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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To determine clinical and/or pathological response rates with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer.
Periodo de tiempo: Length of time for a response to treatment
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Length of time for a response to treatment
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To evaluate the toxicity of the combination regimen in this subject population.
Periodo de tiempo: Length of time for a response to treatment
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Length of time for a response to treatment
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To access EGFR expression by immunohistochemical assay.
Periodo de tiempo: Length of time for a response to treatment
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Length of time for a response to treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: E-mail: ClinicalTrials@ ImClone.com, Eli Lilly and Company
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 septiembre de 2003
Finalización primaria (Actual)
1 de junio de 2006
Finalización del estudio (Actual)
1 de junio de 2006
Fechas de registro del estudio
Enviado por primera vez
25 de junio de 2003
Primero enviado que cumplió con los criterios de control de calidad
26 de junio de 2003
Publicado por primera vez (Estimar)
27 de junio de 2003
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
8 de abril de 2010
Última actualización enviada que cumplió con los criterios de control de calidad
7 de abril de 2010
Última verificación
1 de abril de 2010
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias urogenitales
- Neoplasias por sitio
- Enfermedades Peritoneales
- Neoplasias Genitales Femeninas
- Enfermedades anexiales
- Neoplasias del Sistema Digestivo
- Enfermedades de las trompas de Falopio
- Neoplasias Abdominales
- Neoplasias
- Neoplasias de las trompas de Falopio
- Neoplasias Peritoneales
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, fitogénicos
- Agentes antineoplásicos inmunológicos
- Carboplatino
- Paclitaxel
- Cetuximab
Otros números de identificación del estudio
- CA225-009
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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