A Phase I Study of Liposomal Doxorubicin (Doxil) and Prolonged Etoposide As Second Line Therapy in Ovarian, Tubal and Peritoneal Carcinoma
etoposide
+ pegylated liposomal doxorubicin hydrochloride
Enfermedades Urogenitales+19
+ Enfermedades Genitales
+ Enfermedades Anexiales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Determine the optimal dose of doxorubicin HCl liposomal and prolonged oral etoposide in patients with recurrent or persistent ovarian, tubal, and peritoneal carcinoma. II. Determine the nature and degree of toxicity of this therapy in these patients. III. Evaluate the response rate of patients with measurable disease. OUTLINE: This is a dose escalation, multicenter study of etoposide and doxorubicin HCl liposome. Patients receive doxorubicin HCl liposome IV over 1 hour on day 1, followed by oral etoposide for 8-14 days beginning on day 2. For patients who achieve partial or complete response, treatment repeats every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity. For patients with stable disease, treatment repeats every 4 weeks for 6 months. In the absence of dose limiting toxicity (DLT) in the first 3 patients treated, subsequent cohorts of 3-6 patients each receive doses of etoposide for more prolonged periods. After 14 days of oral etoposide, the dose of doxorubicin HCl liposome is escalated. The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience DLT. Patients are followed every 3 months for 1 year, then until death. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 1 year.
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 persistent ovarian, tubal, or peritoneal carcinoma of the following cell types: Serous adenocarcinoma Mucinous adenocarcinoma Clear cell adenocarcinoma Transitional cell Endometrioid adenocarcinoma Undifferentiated carcinoma Mixed epithelial carcinoma Malignant Brenner tumor Adenocarcinoma not otherwise specified Must not be eligible for any other higher priority phase II or phase III GOG protocol PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT/SGPT/GGT no greater than 2.5 times normal Alkaline phosphatase no greater than 2.5 times normal No acute hepatitis Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance greater than 50 mL/min Cardiovascular: LVEF within normal range as determined by MUGA No congestive heart failure or unstable angina No myocardial infarction within the past 6 months Prior abnormal cardiac conduction (e.g., bundle branch block, heart block) allowed if stable for at least 6 months Other: No significant infection No septicemia Body surface area at least 1 m2 Adequate intestinal function (i.e., does not require IV hydration or nutritional support) No severe gastrointestinal bleeding No other invasive malignancies within the past 5 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy and recovered Chemotherapy: Must have received at least 1 prior cisplatin-paclitaxel based regimen At least 3 weeks since prior chemotherapy and recovered No prior anthracycline therapy Endocrine therapy: At least 3 weeks since prior endocrine therapy and recovered Radiotherapy: No prior radiotherapy to more than 10% of bone marrow Surgery: At least 3 weeks since prior surgery 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 63 ubicaciones
University of Alabama Comprehensive Cancer Center
Birmingham, United StatesAbrir University of Alabama Comprehensive Cancer Center en Google MapsCCOP - Greater Phoenix
Phoenix, United StatesUSC/Norris Comprehensive Cancer Center
Los Angeles, United StatesJonsson Comprehensive Cancer Center, UCLA
Los Angeles, United States