- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00002993
Combination Chemotherapy in Treating Patients With Recurrent or Advanced Cancer of the Uterus
Evaluation of Mitomycin, Doxorubicin and Cisplatin in the Treatment of Recurrent or Advanced Uterine Sarcomas
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 II trial to study the effectiveness of combination chemotherapy with mitomycin, doxorubicin, and cisplatin in treating patients with recurrent or advanced cancer of the uterus.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES: I. Estimate the antitumor activity of the combination of mitomycin, doxorubicin, and cisplatin (MAP) in patients with recurrent or advanced uterine sarcomas. II. Determine the nature and degree of toxicity of MAP chemotherapy in this cohort of patients.
OUTLINE: Patients receive IV doxorubicin, mitomycin, and cisplatin over 3 hours once every 3 weeks, for a minimum of 1 course. Patients who have complete response, partial response, or stable disease will continue for at least 3 courses. If side effects are not severe, patients may remain on the study regimen at the investigator's discretion for a maximum of 6 courses. All patients are followed until death.
PROJECTED ACCRUAL: The first stage of accrual is anticipated to accrue 20 evaluable patients in approximately 12 months. If indicated, a second stage will accrue approximately 10 evaluable patients.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama Comprehensive Cancer Center
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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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Orange, California, Estados Unidos, 92868
- Chao Family Comprehensive Cancer Center
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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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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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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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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota Cancer Center
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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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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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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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Rochester, New York, Estados Unidos, 14642
- University of Rochester 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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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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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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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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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908
- Cancer Center, University of Virginia HSC
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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 confirmed advanced, persistent, or recurrent uterine sarcoma Documented disease progression after local therapy Measurable disease consisting of abdominal, pelvic, chest, or other masses that can be defined in at least two dimensions by palpation, x-ray, computed tomography or ultrasound
PATIENT CHARACTERISTICS: Age: No age specified Performance status: Karnofsky 50%-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.5 times normal Cardiovascular: Ejection fraction within institutional normal limits Pulmonary: Not specified Other: No active infection No concurrent second malignancy other than nonmelanoma skin cancer Must be disease free of any prior malignancy for at least 5 years and not received any treatments with chemotherapy or radiation therapy for that malignancy
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 6 weeks since radiotherapy Recovered from effects of radiotherapy Surgery: Recovered from effects of surgery
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: John H. Edmonson, MD, Mayo 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
- Neoplasias De Tejidos Conectivos Y Blandos
- Neoplasias por tipo histológico
- Neoplasias
- Sarcoma
- Mecanismos moleculares de acción farmacológica
- Inhibidores de la síntesis de ácidos nucleicos
- Inhibidores de enzimas
- Agentes antineoplásicos
- Agentes alquilantes
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Antibióticos, Antineoplásicos
- Doxorrubicina
- Doxorrubicina liposomal
- Mitomicinas
- Mitomicina
Otros números de identificación del estudio
- CDR0000065540
- GOG-87I
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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