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Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

12 febbraio 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Fase

Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Australia
- New South Wales
  - Camperdown, New South Wales, Australia, 1450
    - Australia New Zealand Gynaecological Oncology Trials Group
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Centre - Calgary
Giappone
- - Kagoshima City, Giappone, 892-8580
    - Kagoshima City Hospital
Norvegia
- - Oslo, Norvegia, N-0310
    - Norwegian Radium Hospital
Stati Uniti
- Alabama
  - Birmingham, Alabama, Stati Uniti, 35294
    - Comprehensive Cancer Center at University of Alabama at Birmingham
- Arizona
  - Phoenix, Arizona, Stati Uniti, 85006-2726
    - CCOP - Western Regional, Arizona
- California
  - Los Angeles, California, Stati Uniti, 90095-1740
    - Jonsson Comprehensive Cancer Center at UCLA
  - Los Gatos, California, Stati Uniti, 95032
    - Women's Cancer Center - Los Gatos
  - Orange, California, Stati Uniti, 92868
    - Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- Colorado
  - Denver, Colorado, Stati Uniti, 80010
    - University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Connecticut
  - New Haven, Connecticut, Stati Uniti, 06520-8028
    - Yale Comprehensive Cancer Center at Yale University School of Medicine
- Delaware
  - Newark, Delaware, Stati Uniti, 19713
    - CCOP - Christiana Care Health Services
- District of Columbia
  - Washington, District of Columbia, Stati Uniti, 20307-5001
    - Walter Reed Army Medical Center
- Florida
  - Tampa, Florida, Stati Uniti, 33612-9497
    - H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
- Hawaii
  - Honolulu, Hawaii, Stati Uniti, 96813
    - MBCCOP - Hawaii
- Illinois
  - Chicago, Illinois, Stati Uniti, 60637-1470
    - University of Chicago Cancer Research Center
  - Chicago, Illinois, Stati Uniti, 60612
    - MBCCOP - University of Illinois at Chicago
  - Chicago, Illinois, Stati Uniti, 60612-3824
    - Rush University Medical Center
  - Decatur, Illinois, Stati Uniti, 62794-9640
    - CCOP - Central Illinois
  - Evanston, Illinois, Stati Uniti, 60201
    - CCOP - Evanston
  - Hinsdale, Illinois, Stati Uniti, 60521
  - Urbana, Illinois, Stati Uniti, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Indianapolis, Indiana, Stati Uniti, 46202-5289
    - Indiana University Cancer Center
  - South Bend, Indiana, Stati Uniti, 46617
    - Saint Joseph Regional Medical Center
- Iowa
  - Iowa City, Iowa, Stati Uniti, 52242-1002
    - Holden Comprehensive Cancer Center at University of Iowa
- Kentucky
  - Lexington, Kentucky, Stati Uniti, 40536-0084
    - Markey Cancer Center at University of Kentucky Chandler Medical Center
- Massachusetts
  - Boston, Massachusetts, Stati Uniti, 02111
    - TUFTS - New England Medical Center
  - Worcester, Massachusetts, Stati Uniti, 01605-2982
    - UMASS Memorial Cancer Center - University Campus
- Michigan
  - Ann Arbor, Michigan, Stati Uniti, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Grand Rapids, Michigan, Stati Uniti, 49503
    - CCOP - Grand Rapids
  - Kalamazoo, Michigan, Stati Uniti, 49007-3731
    - CCOP - Kalamazoo
- Minnesota
  - Minneapolis, Minnesota, Stati Uniti, 55455
    - University of Minnesota Cancer Center
  - Rochester, Minnesota, Stati Uniti, 55905-0001
    - Mayo Clinic Cancer Center
  - Saint Louis Park, Minnesota, Stati Uniti, 55416
    - CCOP - Metro-Minnesota
- Mississippi
  - Jackson, Mississippi, Stati Uniti, 39216-4505
    - University of Mississippi Medical Center
  - Keesler AFB, Mississippi, Stati Uniti, 39534-2576
    - Keesler Medical Center - Keesler Air Force Base
- Missouri
  - Columbia, Missouri, Stati Uniti, 65203
    - Ellis Fischel Cancer Center at University of Missouri - Columbia
  - Kansas City, Missouri, Stati Uniti, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, Stati Uniti, 63110
    - Siteman Cancer Center at Barnes-Jewish Hospital
  - Springfield, Missouri, Stati Uniti, 65807
    - CCOP - Cancer Research for the Ozarks
- Nebraska
  - Omaha, Nebraska, Stati Uniti, 68106
    - CCOP - Missouri Valley Cancer Consortium
- New Jersey
  - Camden, New Jersey, Stati Uniti, 08103-1489
    - Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
- New York
  - Brooklyn, New York, Stati Uniti, 11203
    - SUNY Downstate Medical Center
  - Buffalo, New York, Stati Uniti, 14263-0001
    - Roswell Park Cancer Institute
  - Manhasset, New York, Stati Uniti, 11030
    - North Shore University Hospital
  - New York, New York, Stati Uniti, 10021
    - Memorial Sloan-Kettering Cancer Center
  - Stony Brook, New York, Stati Uniti, 11790-7775
    - Long Island Cancer Center at Stony Brook University Hospital
- North Carolina
  - Chapel Hill, North Carolina, Stati Uniti, 27599-7570
    - Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  - Durham, North Carolina, Stati Uniti, 27710
    - Duke Comprehensive Cancer Center
  - Greenville, North Carolina, Stati Uniti, 27858
    - Gynecologic Oncology Network
  - Winston-Salem, North Carolina, Stati Uniti, 27157-1065
    - Comprehensive Cancer Center at Wake Forest University
- Ohio
  - Cincinnati, Ohio, Stati Uniti, 45267-0520
    - Charles M. Barrett Cancer Center at University Hospital
  - Cleveland, Ohio, Stati Uniti, 44124
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, Stati Uniti, 44106
    - Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
  - Columbus, Ohio, Stati Uniti, 43210-1240
    - Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
- Oklahoma
  - Oklahoma City, Oklahoma, Stati Uniti, 73104
    - University of Oklahoma College of Medicine
- Oregon
  - Portland, Oregon, Stati Uniti, 97225
    - CCOP - Columbia River Oncology Program
- Pennsylvania
  - Abington, Pennsylvania, Stati Uniti, 19001-3788
    - Abington Memorial Hospital
  - Danville, Pennsylvania, Stati Uniti, 17822-2001
    - CCOP - Geisinger Clinic and Medical Center
  - Hershey, Pennsylvania, Stati Uniti, 17033-0850
    - Penn State Cancer Institute at Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, Stati Uniti, 19104-4283
    - Abramson Cancer Center of the University of Pennsylvania
  - Philadelphia, Pennsylvania, Stati Uniti, 19111
    - Fox Chase-Temple Cancer Center
  - Philadelphia, Pennsylvania, Stati Uniti, 19107
    - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  - Pittsburgh, Pennsylvania, Stati Uniti, 15213-3180
    - UPMC Cancer Center at Magee-Womens Hospital
- Tennessee
  - Knoxville, Tennessee, Stati Uniti, 37917
    - Southeast Gynecologic Oncology Associates
  - Nashville, Tennessee, Stati Uniti, 37232-2516
    - Vanderbilt-Ingram Cancer Center
- Texas
  - Dallas, Texas, Stati Uniti, 75390-9032
    - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  - Galveston, Texas, Stati Uniti, 77555-0587
    - University of Texas Medical Branch
  - Houston, Texas, Stati Uniti, 77030-4009
    - M.D. Anderson Cancer Center at University of Texas
  - Temple, Texas, Stati Uniti, 76508
    - CCOP - Scott and White Hospital
- Vermont
  - Burlington, Vermont, Stati Uniti, 05401
    - Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus
- Virginia
  - Charlottesville, Virginia, Stati Uniti, 22908
    - University of Virginia Cancer Center
- Washington
  - Seattle, Washington, Stati Uniti, 98109-1024
    - Fred Hutchinson Cancer Research Center
  - Tacoma, Washington, Stati Uniti, 98405
    - MultiCare Regional Cancer Center at Tacoma General Hospital
- Wisconsin
  - Madison, Wisconsin, Stati Uniti, 53792-6188
    - University of Wisconsin Comprehensive Cancer Center
  - Marshfield, Wisconsin, Stati Uniti, 54449
    - CCOP - Marshfield Clinic Research Foundation

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Mascheramento: Nessuno (etichetta aperta)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Gynecologic Oncology Group

Collaboratori

Bristol-Myers Squibb

National Cancer Institute (NCI)

Investigatori

Cattedra di studio: Angeles A. Secord, MD, Duke Cancer Institute
Deborah K. Armstrong, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Nita Maihle, PhD, Yale University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Secord AA, Blessing JA, Armstrong DK, Rodgers WH, Miner Z, Barnes MN, Lewandowski G, Mannel RS; Gynecologic Oncology Group. Phase II trial of cetuximab and carboplatin in relapsed platinum-sensitive ovarian cancer and evaluation of epidermal growth factor receptor expression: a Gynecologic Oncology Group study. Gynecol Oncol. 2008 Mar;108(3):493-9. doi: 10.1016/j.ygyno.2007.11.029. Epub 2008 Jan 14.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2004

Completamento primario (Effettivo)

1 aprile 2006

Date di iscrizione allo studio

Primo inviato

8 luglio 2004

Primo inviato che soddisfa i criteri di controllo qualità

9 luglio 2004

Primo Inserito (Stima)

12 luglio 2004

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

14 febbraio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 febbraio 2014

Ultimo verificato

1 febbraio 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

GOG-0146P
BMS-CA225-019
CDR0000371712

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .