Phase II Study of Doxil and Paclitaxel in Patients With Endometrial, Tubal, and Sarcomas of Gynecologic Origin
paclitaxel
+ pegylated liposomal doxorubicin hydrochloride
Enfermedades Urogenitales+17
+ Enfermedades Genitales
+ Enfermedades Anexiales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 1997
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Determine the response rate and duration of response to doxorubicin HCl liposome and paclitaxel in patients with endometrial cancer, tubal cancers, and sarcomas and carcinosarcomas (mixed mesodermal tumors) of gynecologic origin. II. Define the safety profile of the combination of doxorubicin HCl liposome and paclitaxel in this patient population. OUTLINE: Patients are stratified into two groups. Group 1 consists of patients with untreated endometrial and tubal cancers and Group 2 consists of patients with sarcomas and carcinosarcomas (mixed mesodermal tumors) of gynecologic origin subdivided into no or prior therapy. Patients receive doxorubicin HCl liposome intravenously on day 1 of each treatment course. Paclitaxel is administered intravenously weekly on days 1, 8, and 15 of each course. Courses are repeated every 21 days. Treatment continues in the absence of unacceptable toxic effects or disease progression. Patients are followed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter. PROJECTED ACCRUAL: A total of 28-60 patients will be accrued for this study.
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.Hasta 120 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 or cytologically confirmed recurrent or refractory carcinoma of the endometrium or fallopian tubes or sarcomas of gynecologic origin including mixed mesodermal sarcomas Documented recurrence or persistence of disease after appropriate surgical and/or radiation therapy Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Platelet count at least 50,000/mm3 Granulocyte count at least 1,000/mm3 Hepatic: SGOT and SGPT no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than 3 times ULN Renal: Creatinine less than 2.5 mg/dL Cardiovascular: MUGA at least lower limit of normal Normal ejection fraction and/or stable cardiac status Other: No medical or social factors that would interfere with compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious concurrent illness requiring immediate therapy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 months since prior combined modality or adjuvant chemotherapy Prior doxorubicin allowed if cumulative dose is recorded Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: At least 30 days since prior noncytotoxic experimental antiemetic or antifungal investigational drugs
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 5 ubicaciones
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, United StatesAbrir NYU School of Medicine's Kaplan Comprehensive Cancer Center en Google MapsNew York Presbyterian Hospital - Cornell Campus
New York, United StatesMount Sinai Medical Center, NY
New York, United StatesAlbert Einstein Comprehensive Cancer Center
The Bronx, United States