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

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00086892
Collaborator
National Cancer Institute (NCI) (NIH), Bristol-Myers Squibb (Industry)
76
Locations

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jun 1, 2004
Actual Primary Completion Date :
Apr 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Gynecologic Oncology Group
    • National Cancer Institute (NCI)
    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gynecologic Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00086892
    Other Study ID Numbers:
    • GOG-0146P
    • BMS-CA225-019
    • CDR0000371712
    First Posted:
    Jul 12, 2004
    Last Update Posted:
    Feb 14, 2014
    Last Verified:
    Feb 1, 2014
    Keywords provided by Gynecologic Oncology Group
    recurrent ovarian epithelial cancer
    primary peritoneal cavity cancer
    Additional relevant MeSH terms:
    Carboplatin
    Cetuximab

    Study Results

    No Results Posted as of Feb 14, 2014