- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00085332
Docetaxel in Treating Patients With Recurrent or Persistent Endometrial Carcinoma (Cancer)
A Phase II Evaluation of Weekly Docetaxel (NSC #628503) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with recurrent or persistent endometrial carcinoma (cancer).
Descripción general del estudio
Descripción detallada
OBJECTIVES:
- Determine the antitumor activity of docetaxel in patients with recurrent or persistent endometrial carcinoma.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-18 months.
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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New South Wales
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Camperdown, New South Wales, Australia, 1450
- Australia New Zealand Gynaecological Oncology Trials Group
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Alberta
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Calgary, Alberta, Canadá, T2N 4N2
- Tom Baker Cancer Centre - Calgary
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294-3300
- Comprehensive Cancer Center at University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, Estados Unidos, 85006-2726
- CCOP - Western Regional, Arizona
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California
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Los Angeles, California, Estados Unidos, 90095-1740
- Jonsson Comprehensive Cancer Center at UCLA
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Los Gatos, California, Estados Unidos, 95032
- Women's Cancer Center - Los Gatos
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Orange, California, Estados Unidos, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
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Colorado
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Denver, Colorado, Estados Unidos, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520-8028
- Yale Comprehensive Cancer Center
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Delaware
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Newark, Delaware, Estados Unidos, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20307-5001
- Walter Reed Army Medical Center
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Florida
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Tampa, Florida, Estados Unidos, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
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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, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Estados Unidos, 60612
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, Estados Unidos, 60612-3824
- Rush University Medical Center
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Decatur, Illinois, Estados Unidos, 62794-9640
- CCOP - Central Illinois
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Evanston, Illinois, Estados Unidos, 60201
- CCOP - Evanston
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Urbana, Illinois, Estados Unidos, 61801
- CCOP - Carle Cancer Center
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202-5289
- Indiana University Cancer Center
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South Bend, Indiana, Estados Unidos, 46617
- Saint Joseph Regional Medical Center
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536-0084
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02111
- Cancer Center at Tufts - New England Medical Center
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Worcester, Massachusetts, Estados Unidos, 01605-2982
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106
- CCOP - Michigan Cancer Research Consortium
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Grand Rapids, Michigan, Estados Unidos, 49503
- CCOP - Grand Rapids
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Kalamazoo, Michigan, Estados Unidos, 49007-3731
- CCOP - Kalamazoo
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota Cancer Center
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Rochester, Minnesota, Estados Unidos, 55905-0001
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- CCOP - Metro-Minnesota
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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 Air Force Base
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Missouri
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Columbia, Missouri, Estados Unidos, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, Estados Unidos, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Estados Unidos, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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Springfield, Missouri, Estados Unidos, 65807
- CCOP - Cancer Research for the Ozarks
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68106
- CCOP - Missouri Valley Cancer Consortium
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New Jersey
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Camden, New Jersey, Estados Unidos, 08103-1489
- Cancer Institute of New Jersey at the Cooper University Hospital
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New York
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Brooklyn, New York, Estados Unidos, 11203
- SUNY Downstate Medical Center
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Buffalo, New York, Estados Unidos, 14263-0001
- Roswell Park Cancer Institute
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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, 11790-7775
- Long Island Cancer Center at Stony Brook University Hospital
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7570
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
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Greenville, North Carolina, Estados Unidos, 27858
- Gynecologic Oncology Network
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Winston-Salem, North Carolina, Estados Unidos, 27157-1065
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45267-0520
- Charles M. Barrett Cancer Center at University Hospital
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Cleveland, Ohio, Estados Unidos, 44124
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Estados Unidos, 44106
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
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Columbus, Ohio, Estados Unidos, 43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- University of Oklahoma College of Medicine
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Oregon
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Portland, Oregon, Estados Unidos, 97225
- CCOP - Columbia River Oncology Program
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Pennsylvania
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Abington, Pennsylvania, Estados Unidos, 19001-3788
- Abington Memorial Hospital
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Danville, Pennsylvania, Estados Unidos, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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Hershey, Pennsylvania, Estados Unidos, 17033-0850
- Penn State Cancer Institute at 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, 19104-4283
- Abramson Cancer Center of the University of Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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Pittsburgh, Pennsylvania, Estados Unidos, 15213-3180
- UPMC Cancer Center at Magee-Womens Hospital
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Tennessee
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Knoxville, Tennessee, Estados Unidos, 37917
- Southeast Gynecologic Oncology Associates
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Nashville, Tennessee, Estados Unidos, 37232-2516
- Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
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Texas
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Dallas, Texas, Estados Unidos, 75390-9032
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Galveston, Texas, Estados Unidos, 77555-0587
- University of Texas Medical Branch
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Houston, Texas, Estados Unidos, 77030-4009
- MD Anderson Cancer Center at University of Texas
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Temple, Texas, Estados Unidos, 76508
- CCOP - Scott and White Hospital
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Vermont
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Burlington, Vermont, Estados Unidos, 05401
- Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908
- Cancer Center at the University of Virginia
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Washington
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Seattle, Washington, Estados Unidos, 98109-1024
- Fred Hutchinson Cancer Research Center
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Tacoma, Washington, Estados Unidos, 98405
- MultiCare Regional Cancer Center at Tacoma General Hospital
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792-6188
- University of Wisconsin Comprehensive Cancer Center
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Marshfield, Wisconsin, Estados Unidos, 54449
- CCOP - Marshfield Clinic Research Foundation
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Kagoshima City, Japón, 892-8580
- Kagoshima City Hospital
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Oslo, Noruega, N-0310
- Norwegian Radium 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 confirmed endometrial carcinoma
- Recurrent or persistent disease
- Refractory to curative or standard therapy
Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
At least 1 target lesion
- Tumors within a previously irradiated field are not considered target lesions
Received 1 prior chemotherapy regimen for endometrial carcinoma, including high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
- One additional non-cytotoxic regimen for recurrent or persistent disease allowed, including monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
- Ineligible for a higher priority GOG protocol
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- GOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- SGOT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin ≤ 1.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No neuropathy (sensory and motor) ≥ grade 2
- No active infection requiring antibiotics
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- At least 3 weeks since prior biologic or immunologic therapy for malignant tumor
- No concurrent prophylactic growth factors
- No concurrent prophylactic thrombopoietic agents
Chemotherapy
- See Disease Characteristics
- Recovered from prior chemotherapy
- No more than 1 prior cytotoxic chemotherapy regimen (single or combination cytotoxic drugs)
Endocrine therapy
- At least 1 week since prior hormonal therapy for malignant tumor
- Concurrent hormone replacement therapy allowed
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
Surgery
- Recovered from prior surgery
Other
- At least 3 weeks since other prior therapy for malignant tumor
- No prior anticancer therapy that would preclude current protocol therapy
- No concurrent amifostine or other protective reagents
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Enmascaramiento: Ninguno (etiqueta abierta)
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Agustin Garcia, MD, Premiere Oncology
Publicaciones y enlaces útiles
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
Términos MeSH relevantes adicionales
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias Glandulares y Epiteliales
- Neoplasias Uterinas
- Neoplasias Genitales Femeninas
- Enfermedades uterinas
- Carcinoma
- Neoplasias Endometriales
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Docetaxel
Otros números de identificación del estudio
- GOG-0129N
- CDR0000368634
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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