Phase II Study of Gemcitabine in the Treatment of Patients With Metastatic Breast Cancer Previously Treated With Adriamycin and Taxol
gemcitabine hydrochloride
Enfermedades de la Mama+2
+ Neoplasias
+ Neoplasias por Sitio
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de junio de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the objective response rate to gemcitabine in women with metastatic breast cancer previously treated with two to four chemotherapy regimens, including doxorubicin and paclitaxel. Characterize the nature of toxicity of gemcitabine in this patient population. Determine the response duration to gemcitabine in this patient population. OUTLINE: Patients receive gemcitabine IV over 30 minutes once weekly for 3 consecutive weeks (days 1, 8, and 15) followed by 1 week of rest. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxic effects. Patients are followed until death. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 13 months.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 30 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
DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer Bidimensionally measurable disease No bone scan abnormalities alone Lytic lesions in conjunction with bone scan abnormalities allowed No pure blastic bone metastases No pleural or peritoneal effusions No previously irradiated lesions Must have received 2-4 prior chemotherapy regimens, including paclitaxel and doxorubicin, for breast cancer Brain metastases allowed if other measurable disease exists No uncontrolled or life threatening brain lesions No carcinomatous meningitis Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: AST/ALT no greater than 5 times upper limit of normal Renal: Calcium no greater than 11.0 mg/dL Other: Not pregnant Negative pregnancy test No history of other malignancy except carcinoma in situ of the cervix or curatively treated nonmelanoma skin cancer No other serious medical illnesses, including severe infection and severe malnutrition PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered No other concurrent chemotherapy Endocrine therapy: Prior hormonal therapies for stage IV disease and/or adjuvant therapy allowed At least 3 weeks since prior hormonal therapy Radiotherapy: See Disease Characteristics No prior radiotherapy to greater than 30% of the marrow bearing bone At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy to the only measurable lesion Surgery: Recovered from prior surgery No concurrent surgery to the only measurable lesion Other: No concurrent nonprotocol treatment
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Memorial Sloan-Kettering Cancer Center
New York, United StatesAbrir Memorial Sloan-Kettering Cancer Center en Google Maps