Evaluation of Topotecan in the Treatment of Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus
topotecan hydrochloride
Neoplasias
+ Neoplasias por tipo histológico
+ Sarcoma
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de junio de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Estimate the antitumor activity of topotecan in patients with recurrent or refractory carcinosarcoma of the uterus who have failed standard therapy. II. Determine the nature and degree of toxic effects of topotecan in these patients. OUTLINE: Patients receive topotecan IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for a minimum of 1 course in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease continue treatment for at least three courses. Patients are followed every 4 months for 2 years, every 6 months for 3 years, and then periodically thereafter until death. PROJECTED ACCRUAL: Approximately 25-40 patients will be accrued for this study within 2 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.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.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory carcinosarcoma (mixed mesodermal tumors) of the uterus Measurable disease PATIENT CHARACTERISTICS: Age: Not specified Performance Status: GOG 0-2 Life Expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 20 mL/min Other: No invasive malignancies within the past 5 years except nonmelanomatous skin cancer No significant infection PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior topotecan or camptothecin therapy No more than 1 prior chemotherapy regimen (either single or combination chemotherapy) Endocrine therapy: At least 3 weeks since prior endocrine therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Prior surgery allowed and recovered
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 46 ubicaciones
University of Alabama Comprehensive Cancer Center
Birmingham, United StatesAbrir University of Alabama Comprehensive Cancer Center en Google MapsJonsson Comprehensive Cancer Center, UCLA
Los Angeles, United StatesCommunity Hospital of Los Gatos
Los Gatos, United StatesChao Family Comprehensive Cancer Center
Orange, United States