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

2014년 2월 12일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 마스킹: 없음(오픈 라벨)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Gynecologic Oncology Group

협력자

Bristol-Myers Squibb
National Cancer Institute (NCI)

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2004년 6월 1일

기본 완료 (실제)

2006년 4월 1일

연구 등록 날짜

최초 제출

2004년 7월 8일

QC 기준을 충족하는 최초 제출

2004년 7월 9일

처음 게시됨 (추정)

2004년 7월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 2월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 2월 12일

마지막으로 확인됨

2014년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GOG-0146P
  • BMS-CA225-019
  • CDR0000371712

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다