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

12 februari 2014 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Fase

Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Masker: Geen (open label)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Gynecologic Oncology Group

Medewerkers

Bristol-Myers Squibb

National Cancer Institute (NCI)

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

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.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2004

Primaire voltooiing (Werkelijk)

1 april 2006

Studieregistratiedata

Eerst ingediend

8 juli 2004

Eerst ingediend dat voldeed aan de QC-criteria

9 juli 2004

Eerst geplaatst (Schatting)

12 juli 2004

Updates van studierecords

Laatste update geplaatst (Schatting)

14 februari 2014

Laatste update ingediend die voldeed aan QC-criteria

12 februari 2014

Laatst geverifieerd

1 februari 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

GOG-0146P
BMS-CA225-019
CDR0000371712

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .