Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
12 février 2014 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New South Wales
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Camperdown, New South Wales, Australie, 1450
- Australia New Zealand Gynaecological Oncology Trials Group
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre - Calgary
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Kagoshima City, Japon, 892-8580
- Kagoshima City Hospital
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Oslo, Norvège, N-0310
- Norwegian Radium Hospital
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Alabama
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Birmingham, Alabama, États-Unis, 35294
- Comprehensive Cancer Center at University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, États-Unis, 85006-2726
- CCOP - Western Regional, Arizona
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California
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Los Angeles, California, États-Unis, 90095-1740
- Jonsson Comprehensive Cancer Center at UCLA
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Los Gatos, California, États-Unis, 95032
- Women's Cancer Center - Los Gatos
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Orange, California, États-Unis, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
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Colorado
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Denver, Colorado, États-Unis, 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, États-Unis, 06520-8028
- Yale Comprehensive Cancer Center at Yale University School of Medicine
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Delaware
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Newark, Delaware, États-Unis, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, États-Unis, 20307-5001
- Walter Reed Army Medical Center
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Florida
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Tampa, Florida, États-Unis, 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, États-Unis, 96813
- MBCCOP - Hawaii
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Illinois
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Chicago, Illinois, États-Unis, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, États-Unis, 60612
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, États-Unis, 60612-3824
- Rush University Medical Center
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Decatur, Illinois, États-Unis, 62794-9640
- CCOP - Central Illinois
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Evanston, Illinois, États-Unis, 60201
- CCOP - Evanston
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Hinsdale, Illinois, États-Unis, 60521
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Urbana, Illinois, États-Unis, 61801
- CCOP - Carle Cancer Center
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Indiana
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Indianapolis, Indiana, États-Unis, 46202-5289
- Indiana University Cancer Center
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South Bend, Indiana, États-Unis, 46617
- Saint Joseph Regional Medical Center
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Iowa
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Iowa City, Iowa, États-Unis, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Lexington, Kentucky, États-Unis, 40536-0084
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 02111
- TUFTS - New England Medical Center
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Worcester, Massachusetts, États-Unis, 01605-2982
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Ann Arbor, Michigan, États-Unis, 48106
- CCOP - Michigan Cancer Research Consortium
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Grand Rapids, Michigan, États-Unis, 49503
- CCOP - Grand Rapids
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Kalamazoo, Michigan, États-Unis, 49007-3731
- CCOP - Kalamazoo
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota Cancer Center
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Rochester, Minnesota, États-Unis, 55905-0001
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, États-Unis, 55416
- CCOP - Metro-Minnesota
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Mississippi
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Jackson, Mississippi, États-Unis, 39216-4505
- University of Mississippi Medical Center
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Keesler AFB, Mississippi, États-Unis, 39534-2576
- Keesler Medical Center - Keesler Air Force Base
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Missouri
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Columbia, Missouri, États-Unis, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, États-Unis, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, États-Unis, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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Springfield, Missouri, États-Unis, 65807
- CCOP - Cancer Research for the Ozarks
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Nebraska
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Omaha, Nebraska, États-Unis, 68106
- CCOP - Missouri Valley Cancer Consortium
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New Jersey
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Camden, New Jersey, États-Unis, 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, États-Unis, 11203
- SUNY Downstate Medical Center
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Buffalo, New York, États-Unis, 14263-0001
- Roswell Park Cancer Institute
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Manhasset, New York, États-Unis, 11030
- North Shore University Hospital
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New York, New York, États-Unis, 10021
- Memorial Sloan-Kettering Cancer Center
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Stony Brook, New York, États-Unis, 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, États-Unis, 27599-7570
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Durham, North Carolina, États-Unis, 27710
- Duke Comprehensive Cancer Center
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Greenville, North Carolina, États-Unis, 27858
- Gynecologic Oncology Network
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Winston-Salem, North Carolina, États-Unis, 27157-1065
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Cincinnati, Ohio, États-Unis, 45267-0520
- Charles M. Barrett Cancer Center at University Hospital
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Cleveland, Ohio, États-Unis, 44124
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, États-Unis, 44106
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
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Columbus, Ohio, États-Unis, 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, États-Unis, 73104
- University of Oklahoma College of Medicine
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Oregon
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Portland, Oregon, États-Unis, 97225
- CCOP - Columbia River Oncology Program
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Pennsylvania
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Abington, Pennsylvania, États-Unis, 19001-3788
- Abington Memorial Hospital
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Danville, Pennsylvania, États-Unis, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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Hershey, Pennsylvania, États-Unis, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, États-Unis, 19104-4283
- Abramson Cancer Center of the University of Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19111
- Fox Chase-Temple Cancer Center
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Philadelphia, Pennsylvania, États-Unis, 19107
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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Pittsburgh, Pennsylvania, États-Unis, 15213-3180
- UPMC Cancer Center at Magee-Womens Hospital
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Tennessee
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Knoxville, Tennessee, États-Unis, 37917
- Southeast Gynecologic Oncology Associates
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Nashville, Tennessee, États-Unis, 37232-2516
- Vanderbilt-Ingram Cancer Center
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Texas
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Dallas, Texas, États-Unis, 75390-9032
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Galveston, Texas, États-Unis, 77555-0587
- University of Texas Medical Branch
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Houston, Texas, États-Unis, 77030-4009
- M.D. Anderson Cancer Center at University of Texas
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Temple, Texas, États-Unis, 76508
- CCOP - Scott and White Hospital
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Vermont
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Burlington, Vermont, États-Unis, 05401
- Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus
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Virginia
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Charlottesville, Virginia, États-Unis, 22908
- University of Virginia Cancer Center
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Washington
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Seattle, Washington, États-Unis, 98109-1024
- Fred Hutchinson Cancer Research Center
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Tacoma, Washington, États-Unis, 98405
- MultiCare Regional Cancer Center at Tacoma General Hospital
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Wisconsin
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Madison, Wisconsin, États-Unis, 53792-6188
- University of Wisconsin Comprehensive Cancer Center
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Marshfield, Wisconsin, États-Unis, 54449
- CCOP - Marshfield Clinic Research Foundation
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Masquage: Aucun (étiquette ouverte)
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Angeles A. Secord, MD, Duke Cancer Institute
- Deborah K. Armstrong, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Nita Maihle, PhD, Yale University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juin 2004
Achèvement primaire (Réel)
1 avril 2006
Dates d'inscription aux études
Première soumission
8 juillet 2004
Première soumission répondant aux critères de contrôle qualité
9 juillet 2004
Première publication (Estimation)
12 juillet 2004
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
14 février 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 février 2014
Dernière vérification
1 février 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GOG-0146P
- BMS-CA225-019
- CDR0000371712
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .