- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00003380
Liposomal Doxorubicin and Etoposide in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer
A Phase I Study of Liposomal Doxorubicin (Doxil) and Prolonged Etoposide As Second Line Therapy in Ovarian, Tubal and Peritoneal Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin and etoposide in treating patients who have recurrent or persistent ovarian, fallopian tube, or peritoneal cancer.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Kingston, Ontario, Canadá, K7L 3N6
- NCIC-Clinical Trials Group
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, Estados Unidos, 85006-2726
- CCOP - Greater Phoenix
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California
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Los Angeles, California, Estados Unidos, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles, California, Estados Unidos, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Palo Alto, California, Estados Unidos, 94304
- Women's Cancer Center
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Colorado
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Denver, Colorado, Estados Unidos, 80262
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, Estados Unidos, 20007
- Vincent T. Lombardi Cancer Research Center, Georgetown University
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Florida
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Tampa, Florida, Estados Unidos, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University Hospital - Atlanta
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Atlanta, Georgia, Estados Unidos, 30342-1701
- CCOP - Atlanta Regional
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96813
- MBCCOP - Hawaii
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago Cancer Research Center
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Evanston, Illinois, Estados Unidos, 60201
- CCOP - Evanston
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Springfield, Illinois, Estados Unidos, 62526
- CCOP - Central Illinois
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202-5265
- Indiana University Cancer Center
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa Hospitals and Clinics
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins Oncology Center
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Bethesda, Maryland, Estados Unidos, 20892
- Radiation Oncology Branch
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Bethesda, Maryland, Estados Unidos, 20892
- Medicine Branch
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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01655
- University of Massachusetts Memorial Medical Center
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, Estados Unidos, 48201
- Barbara Ann Karmanos Cancer Institute
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216-4505
- University of Mississippi Medical Center
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Keesler AFB, Mississippi, Estados Unidos, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, Estados Unidos, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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Montana
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Billings, Montana, Estados Unidos, 59101
- CCOP - Montana Cancer Consortium
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68131
- CCOP - Missouri Valley Cancer Consortium
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Jersey
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Camden, New Jersey, Estados Unidos, 08103
- Cooper Hospital/University Medical Center
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New York
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Albany, New York, Estados Unidos, 12208
- Cancer Center of Albany Medical Center
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Brooklyn, New York, Estados Unidos, 11203
- State University of New York Health Science Center at Brooklyn
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Manhasset, New York, Estados Unidos, 11030
- North Shore University Hospital
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New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
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Stony Brook, New York, Estados Unidos, 11790-9832
- State University of New York Health Sciences Center - Stony Brook
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Estados Unidos, 27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Brookview Research, Inc.
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Cancer Center
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Cleveland, Ohio, Estados Unidos, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, Estados Unidos, 43210
- Arthur G. James Cancer Hospital - Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73190
- University of Oklahoma College of Medicine
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Tulsa, Oklahoma, Estados Unidos, 74136
- CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
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Oregon
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Portland, Oregon, Estados Unidos, 97213
- CCOP - Columbia River Program
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Pennsylvania
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Abington, Pennsylvania, Estados Unidos, 19001
- Abington Memorial Hospital
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Hershey, Pennsylvania, Estados Unidos, 17033
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Pennsylvania Hospital
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania Cancer Center
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425-0721
- Medical University of South Carolina
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Spartanburg, South Carolina, Estados Unidos, 29303
- CCOP - Upstate Carolina
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38117
- CCOP - Baptist Cancer Institute
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Texas
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Dallas, Texas, Estados Unidos, 75235-9154
- Simmons Cancer Center - Dallas
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Houston, Texas, Estados Unidos, 77030
- University of Texas - MD Anderson Cancer Center
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Washington
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Seattle, Washington, Estados Unidos, 98195-6043
- University of Washington Medical Center
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Tacoma, Washington, Estados Unidos, 98405
- Tacoma General Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Peter G. Rose, MD, The Cleveland Clinic
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- cáncer epitelial de ovario recurrente
- cáncer de trompa de Falopio
- cáncer primario de cavidad peritoneal
- cistoadenocarcinoma seroso de ovario
- adenocarcinoma indiferenciado de ovario
- cistoadenocarcinoma de células claras de ovario
- adenocarcinoma endometrioide de ovario
- cistoadenocarcinoma mucinoso de ovario
- carcinoma epitelial mixto de ovario
- Tumor de Brenner
Términos MeSH relevantes adicionales
- Neoplasias
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias Genitales Femeninas
- Enfermedades anexiales
- Enfermedades de las trompas de Falopio
- Neoplasias de las trompas de Falopio
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Agentes antineoplásicos, fitogénicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Antibióticos, Antineoplásicos
- Etopósido
- Doxorrubicina
- Doxorrubicina liposomal
Otros números de identificación del estudio
- CDR0000066375
- GOG-9704
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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