An Open-Label Phase II Study in Subjects With Recurrent EGFR-Positive Ovarian Cancer to Investigate the Safety and Efficacy of EMD 72000 Administered as a Single Agent
Colección de datos
Carcinoma+15
+ Enfermedades Urogenitales
+ Enfermedades Anexiales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de abril de 2003
Fecha en la que se inscribió al primer participante.EMD 72000 is an experimental, biological drug. Studies in animals indicate that EMD 72000 blocks a factor found on the surface of many cancer cells. The factor is called epidermal growth factor receptor or EGFR. One type of cancer which frequently contains EGFR is ovarian cancer. This study will test the safety and effects of EMD 72000 in subjects with EGFR-positive recurrent ovarian cancer following standard treatment that has failed.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 38 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Recurrent ovarian cancer (including primary peritoneal cancer) following treatment (e.g., doxorubicin HCL liposome, topotecan, etc.) for primary or secondary platinum-refractory disease * Immunohistochemical evidence of tumor EGFR (HER-1) expression * At least one measurable lesion according to the WHO criteria * Life expectancy ≥ 12 weeks * ECOG performance status 0-1 Exclusion Criteria: * History of prior MAb therapy * History of prior treatment with an EGFR (HER-1) directed therapy * Known brain metastases * Presence of a ≥ Grade 2 pre-existing skin disorder (alopecia is permitted) * Known intercurrent infections or immunosuppression * Actively infected with, or chronic carriers of HBV * Evidence of HCV disease * Previous diagnosis of autoimmune disease * Known hypersensitivity to the administered drugs or any of their components * Receipt of chemotherapy, radiation therapy, or another investigational drug within 30 days of enrollment