Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
12 de febrero de 2014 actualizado por: Gynecologic Oncology Group
A Phase II Evaluation of Cetuximab (C225, NSC #714692) in Combination With Carboplatin (NSC #241240) in the Treatment of Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer
RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy such as carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die. Combining cetuximab with carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin works in treating patients with recurrent ovarian epithelial cancer or primary peritoneal cancer.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Determine the antitumor activity of cetuximab and carboplatin in patients with recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1, 8 , and 15. Patients also receive carboplatin IV after cetuximab administration on day 1. Courses repeat every 21 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 20-65 patients will be accrued for this study.
Tipo de estudio
Intervencionista
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
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
- 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 at Yale University School of Medicine
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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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Hinsdale, Illinois, Estados Unidos, 60521
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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
- 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 - Voorhees
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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, 19104-4283
- Abramson Cancer Center of the University of Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- Fox Chase-Temple Cancer Center
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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
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Texas
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Dallas, Texas, Estados Unidos, 75390-9032
- Simmons Comprehensive 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
- M.D. 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
- University of Virginia Cancer Center
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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
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial or primary peritoneal cancer
- Recurrent disease
Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR ≥ 10 mm by spiral CT scan
- Target lesion not within previously irradiated field
Received 1 prior platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or other organoplatinum compound
- Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
- Patients who had not received prior paclitaxel therapy may have received a second regimen that included paclitaxel
Platinum-sensitive disease
- Treatment-free interval without clinical evidence of progressive disease for more than 6 months after response to a prior platinum-based regimen
- If there is another concurrently active GOG-0146 series protocol (non-platinum-based therapy), must have had a treatment-free interval of more than 12 months unless ineligible for the other protocol* NOTE: *Applies whether or not both protocols are available at the same participating center
- Must have available tissue block or unstained sections from primary tumor, interval debulking, or secondary debulking
- Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- GOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Cardiovascular
- No uncontrolled hypertension
- No unstable angina
- No congestive heart failure
- No uncontrolled arrhythmias within the past 6 months
- No other significant cardiac disease
Neurologic
- No uncontrolled seizure disorder
- No active neurological disease
- No neuropathy > grade 1
Other
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No active infection requiring antibiotics
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior anti-epidermal growth factor receptor (EGFR) antibody therapy
- No prior chimerized or murine monoclonal antibody therapy
- At least 3 weeks since prior biologic or immunologic therapy for the malignancy
Chemotherapy
- See Disease Characteristics
- Recovered from prior chemotherapy
- No prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimens
Endocrine therapy
- At least 1 week since prior hormonal therapy for the malignancy
- Concurrent hormone replacement therapy allowed
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
- No prior radiotherapy to > 25% of bone marrow-bearing areas
Surgery
More than 30 days since prior major surgery and recovered
- Diagnostic biopsy not considered major surgery
Other
- At least 3 weeks since other prior therapy for the malignancy
- No prior tyrosine kinase inhibitors that target the EGFR pathway
- No prior cancer treatment that would preclude study treatment
- No other concurrent investigational agents
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Enmascaramiento: Ninguno (etiqueta abierta)
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Angeles A. Secord, MD, Duke Cancer Institute
- Deborah K. Armstrong, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Nita Maihle, PhD, Yale University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2004
Finalización primaria (Actual)
1 de abril de 2006
Fechas de registro del estudio
Enviado por primera vez
8 de julio de 2004
Primero enviado que cumplió con los criterios de control de calidad
9 de julio de 2004
Publicado por primera vez (Estimar)
12 de julio de 2004
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
14 de febrero de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
12 de febrero de 2014
Última verificación
1 de febrero de 2014
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GOG-0146P
- BMS-CA225-019
- CDR0000371712
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. .