- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00023907
Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
A Phase II Evaluation of Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum and Paclitaxel-Resistant Ovarian or Primary Peritoneal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Determine the antitumor activity of paclitaxel in patients with recurrent or persistent platinum- and paclitaxel-resistant ovarian epithelial or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: Patients receive paclitaxel IV over 1 hour once weekly for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 6-12 months.
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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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 Gatos, California, Estados Unidos, 95032
- Women's Cancer Center at Community Hospital of Los Gatos
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Orange, California, Estados Unidos, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine 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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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
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, Estados Unidos, 60612-3824
- Rush-Presbyterian-St. Luke's Medical Center
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Evanston, Illinois, Estados Unidos, 60201
- CCOP - Evanston
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Springfield, Illinois, Estados Unidos, 62794-9640
- Memorial Medical Center
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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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Maryland
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Bethesda, Maryland, Estados Unidos, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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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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Saint Louis Park, Minnesota, Estados Unidos, 55416
- CCOP - Metro-Minnesota
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Mississippi
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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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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 York
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Buffalo, New York, Estados Unidos, 14263-0001
- Roswell Park Cancer Institute
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7295
- 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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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, 45267-0526
- Charles M. Barrett Cancer Center at University Hospital
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Estados Unidos, 44106
- Ireland Cancer Center
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Columbus, Ohio, Estados Unidos, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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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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Pittsburgh, Pennsylvania, Estados Unidos, 15213-3180
- 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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Nashville, Tennessee, Estados Unidos, 37203
- Genecologic Oncology Network
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Texas
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Galveston, Texas, Estados Unidos, 77555-0587
- University of Texas Medical Branch
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Temple, Texas, Estados Unidos, 76508
- CCOP - Scott and White Hospital
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Wisconsin
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Marshfield, Wisconsin, Estados Unidos, 54449
- CCOP - Marshfield Clinic Research Foundation
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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 recurrent or persistent ovarian epithelial or primary peritoneal cancer
Measurable disease
At least 1 lesion measured in at least 1 dimension
- At least 20 mm by conventional techniques OR
- At least 10 mm by spiral CT scan
At least 1 target lesion
- Tumors within a previously irradiated field considered non-target lesions
Paclitaxel resistant
- Treatment-free interval of less than 6 months duration after treatment with prior paclitaxel OR
- Progression during prior paclitaxel-based therapy
Platinum resistant or refractory
- Treatment-free interval of less than 6 months duration after treatment with prior platinum OR
- Progression during prior platinum-based therapy
- Ineligible for higher priority GOG protocol (any active GOG phase III protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- GOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection requiring antibiotics
- No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No grade 2 or greater neuropathy (sensory and motor)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 3 weeks since prior biologic or immunologic agents for cancer
Chemotherapy:
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy for cancer and recovered
- Received at least 1 but no more than 2 prior platinum-based chemotherapy regimens containing carboplatin, cisplatin, or other organoplatinum compound for primary or recurrent disease
- Initial treatment may include high-dose therapy, consolidation, or extended therapy
- Received at least 1 prior paclitaxel-based chemotherapy regimen
- No prior paclitaxel or docetaxel with a schedule of less than a 3-week interval between doses
- No additional prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
Endocrine therapy:
- At least 1 week since prior hormonal therapy for cancer
- Concurrent hormone replacement therapy allowed
Radiotherapy:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy for cancer and recovered
- No prior radiotherapy to site(s) of measurable disease
- No prior radiotherapy to more than 25% of marrow-bearing areas
Surgery:
- At least 3 weeks since prior surgery for cancer and recovered
Other:
- At least 3 weeks since other prior therapy for cancer
- No prior anticancer treatment that would preclude study
- 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: Maurie Markman, MD, The Cleveland Clinic
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CDR0000068875
- GOG-0126N
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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