- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00071929
Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer
Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have persistent or recurrent endometrial cancer.
Descripción general del estudio
Descripción detallada
OBJECTIVES:
- Determine the antitumor activity of oxaliplatin in terms of response rate in patients with persistent or recurrent endometrial carcinoma that is refractory to curative or established therapy.
- Determine the nature and degree of toxicity of this treatment regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks 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: Approximately 19-51 patients will be accrued for this study.
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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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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Orange, California, Estados Unidos, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer 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 Britain, Connecticut, Estados Unidos, 06052
- New Britain General Hospital
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Delaware
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Newark, Delaware, Estados Unidos, 19713
- CCOP - Christiana Care Health Services
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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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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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South Bend, Indiana, Estados Unidos, 46617
- Saint Joseph Regional Medical Center
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160-7357
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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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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Jackson, Mississippi, Estados Unidos, 39216-4505
- University of Mississippi Medical Center
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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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Brooklyn, New York, Estados Unidos, 11203
- SUNY Downstate Medical 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, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- Ireland Cancer Center
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Cleveland, Ohio, Estados Unidos, 44124
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Estados Unidos, 43222
- Mount Carmel West Hospital
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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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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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Texas
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Temple, Texas, Estados Unidos, 76508
- CCOP - Scott and White Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically confirmed endometrial carcinoma that is refractory to curative therapy or established treatment
- Clinically and/or histologically confirmed persistent or recurrent disease
Measurable disease by physical examination or medical imaging
- Sonography allowed if lesions are clearly defined on initial examination and bidimensionally measurable
- Ascites or pleural effusions not considered measurable
Must have received 1 prior cytotoxic therapy regimen
- May include high-dose therapy, consolidation, or extended therapy after surgical or nonsurgical assessment
1 additional noncytotoxic regimen allowed
Biologic or cytostatic agents include, but are not limited to:
- Monoclonal antibodies
- Cytokines
- Small-molecule inhibitors of signal transduction
- Ineligible for a higher priority GOG protocol
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- GOG 0-2 if received 1 prior therapy regimen
- GOG 0-1 if received 2 prior therapy regimens
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
Cardiovascular
- No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Neurologic
- No sensory or motor neuropathy greater than grade 1
- No residual neuropathy attributed to prior chemotherapy or other chronic conditions (e.g., diabetes, venous stasis, or carpal tunnel syndrome)
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergy to platinum compounds or antiemetics
- No active infection requiring antibiotics
- No other uncontrolled illness
- No other invasive malignancies within the past 5 years except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- At least 14 days since prior pegfilgrastim
- At least 24 hours since other prior growth factors
- At least 3 weeks since prior biologic or immunologic therapy
- No concurrent growth factors during first course of study therapy
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy and recovered
- No more than 1 prior cytotoxic chemotherapy regimen, either single or combination cytotoxic drug therapy
- No prior oxaliplatin
Endocrine therapy
- At least 1 week since prior hormonal therapy directed at tumor
- Concurrent hormone replacement therapy allowed
Radiotherapy
- At least 4 weeks since prior radiotherapy and recovered
Surgery
- Recovered from any recent surgery
Other
- At least 3 weeks since prior therapy for endometrial cancer
- No other concurrent investigational agents
- No prior anticancer therapy that would preclude study participation
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: Paula M. Fracasso, MD, PhD, Washington University Siteman Cancer Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (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
Otros números de identificación del estudio
- CDR0000068235
- GOG-0129K
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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