이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer

2015년 12월 8일 업데이트: Translational Research in Oncology

A Randomized, Double-blind, Placebo Controlled, Multi-center, Phase II Study of Adding AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) to First Line Chemotherapy in Patients With Optimally Debulked ( < 1 cm ) Epithelial Ovarian Cancer

This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.

연구 개요

상태

종료됨

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

170

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 독일
      • Berlin, 독일, 12200
        • Charite Campus Benjamin Franklin
      • Berlin, 독일, 13353
        • University Hospital Charité
      • Bonn, 독일, 53105
        • Universitat Bonn
      • Erlangen, 독일, 91054
        • Universitätsklinikum Erlangen
      • Hamburg, 독일, 20246
        • Universitatsklinikum Hamburg Eppendorf
      • Homburg, 독일, 66421
        • Universitatsklinikum des Saarlandes
      • Kassel, 독일, 34125
        • Klinikum Kassel
      • Munich, 독일, 80637
        • Rotkreuzkrankenhaus Munchen
      • Tubingen, 독일, 72076
        • Universitats Frauenklinik Tubingen
  • 미국
    • California
      • Alhambra, California, 미국, 91801
        • Central Hematology Oncology Medical Group Inc.
      • Burbank, California, 미국, 91505
        • Providence Saint Joseph Medical Center
      • Fullerton, California, 미국, 92835
        • St Jude Heritage Healthcare
      • La Verne, California, 미국, 91750
        • Wilshire Oncology Medical Group Inc
      • Los Angeles, California, 미국, 90033
        • University of Southern California
      • Los Angeles, California, 미국, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, 미국, 90095-1678
        • UCLA
      • Northridge, California, 미국, 91325
        • North Valley Hematology/Oncology Medical Group
      • Oxnard, California, 미국, 93030
        • Ventura County Hematology-Oncology Specialists
      • San Francisco, California, 미국, 94115
        • University of California San Francisco
      • santa Maria, California, 미국, 93454
        • Central Coast Medical Oncology Corporation
    • Connecticut
      • New Haven, Connecticut, 미국, 06510
        • Yale University School Of Medicine
    • Florida
      • Hollywood, Florida, 미국, 33021
        • Memorial Cancer Institute
      • Orlando, Florida, 미국, 32804
        • Florida Hospital Cancer Institute
      • Tampa, Florida, 미국, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, 미국, 30322
        • Winship Cancer Institute Emory University School of Medicine
    • Louisiana
      • Metairie, Louisiana, 미국, 70006
        • Hematology And Oncology Specialists, Llc
    • Minnesota
      • Rochester, Minnesota, 미국, 55905
        • Mayo Clinic
    • Nevada
      • Henderson, Nevada, 미국, 89052
        • Comprehensive Cancer Centers of Nevada
    • North Carolina
      • Asheville, North Carolina, 미국, 28806
        • Hope A Women's Cancer Center
      • Winston-Salem, North Carolina, 미국, 27104
        • Wake Forest University Baptist Medical Center
    • Ohio
      • Toledo, Ohio, 미국, 43614
        • University of Toledo
      • Toledo, Ohio, 미국, 43606
        • The Toledo Hospital
  • 스페인
      • Barcelona, 스페인, 08036
        • Hospital Clinic I Provincial
      • Guadalajara, 스페인, 19002
        • Hospital Universitario de Guadalajara
      • La Laguna, 스페인, 38320
        • Hospital Universitario de Tenerife
      • Madrid, 스페인, 28041
        • Hospital U 12 de Octubre
      • Sevilla, 스페인, 341071
        • Hospital Universitario Virgen Macarena de Sevilla
  • 아일랜드
      • Dublin, 아일랜드
        • St Jame's Hospital
      • Waterford, 아일랜드
        • Waterford Regional Hospital
  • 영국
      • Leeds, 영국, LS97TF
        • Saint James's University Hospital
      • London, 영국, W1T4TJ
        • University College London
      • Northwood, 영국, HA62RN
        • Mount Vernon Cancer Centre
  • 이스라엘
      • Kfar-Saba, 이스라엘, 44281
        • Meir Medical Center
      • Ramat Gan, 이스라엘, 52621
        • Sheba medical center
      • Rehovot, 이스라엘, 76100
        • Kaplan Medical Center
      • Tel Aviv, 이스라엘, 64239
        • Sourasky Medical Center
      • Zrifin, 이스라엘, 70300
        • Asaf Harofe MC
  • 캐나다
    • Alberta
      • Edmonton, Alberta, 캐나다, T6G1Z2
        • Cross Cancer Institute
    • Ontario
      • London, Ontario, 캐나다, N6A4L6
        • London Health Science Center
    • Quebec
      • Montreal, Quebec, 캐나다, H3T1E2
        • Jewish General Hospital
      • Montreal, Quebec, 캐나다, H2L4M1
        • Chum Hopital Notre Dame
  • 프랑스
      • La Roche Sur Yon, 프랑스, 85925
        • Centre Hospitalier Departemental Les Oudairies
      • Lyon, 프랑스, 69373
        • Centre Léon Bérard
      • Neuilly Sur Seine, 프랑스, 92200
        • Clinique Hartmann
      • Paris, 프랑스, 75005
        • Institut Curie

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

Inclusion Criteria:

  • Histologically-confirmed optimally debulked (< 1 cm) FIGO stage III or stage IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
  • Patients should have undergone surgical debulking, by a surgeon experienced in the management of ovarian cancer, with the aim of maximal surgical cytoreduction. All patients must be optimally debulked as defined as having no residual tumor of greater than 1 cm in the post surgical setting.
  • Patients with stage IV disease will be eligible if a positive pleural cytology is the only extra peritoneal disease.
  • Paraffin block (or 10 - 20 unstained slides) and fresh frozen surgical/biopsy specimens of the primary tumor are required at baseline.
  • No prior systemic treatment in the primary disease treatment setting.
  • Female ≥ 18 years of age or legal age.
  • ECOG performance status ≤ 2.
  • Adequate organ and bone marrow function

  • Non diabetic patients or Type 1 or 2 Diabetic Patients:

    • Diabetes must be controlled with HgbA1c < 8% and fasting blood glucose level <160 mg/dL.

  • Patient must be willing and able to comply with scheduled visits, and all study procedures.
  • Informed consent obtained.
  • Patients should be able to commence systemic therapy within 6 weeks of cytoreductive surgery.
  • Life expectancy > 12 weeks.
  • Adequate coagulation parameters (within 14 days prior to randomization), International Normalized Ratio (INR) ≤1.5; Activated Prothrombin Time (APTT) ≤ 1.5 x ULN

Exclusion Criteria:

  • Non-epithelial ovarian cancer, including malignant mixed Mullerian tumors.
  • Borderline tumors (tumors of low malignant potential).
  • Planned intraperitoneal cytotoxic chemotherapy.
  • Prior systemic anticancer therapy for ovarian cancer.
  • Any previous radiotherapy to the abdomen or pelvis.
  • Patients with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless ALL of the following criteria for describing the endometrial carcinoma are met: Stage ≤ Ib, no more than superficial myometrial invasion, no lymphovascular invasion, not poorly differentiated (i.e., not Grade 3 or papillary serous or clear cell).
  • Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri or curatively treated DCIS/LCIS, or non-melanoma or in situ melanoma skin cancer.
  • Prior treatment with a humanized monoclonal antibody anticancer therapeutic.
  • Prior treatment with investigational treatment targeted to IGF axis including, but not limited to, CP 751,871, IM-A12, RO4858696.
  • Previous exposure to AMG 479.
  • Anticipation of a need for a major surgical procedure or radiation therapy during the study.
  • History of hypersensitivity to recombinant proteins.
  • Treatment with radiotherapy, surgery, or an investigational agent within 4 weeks of randomization.
  • Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, grade > 2 peripheral neuropathy, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
  • History of brain metastases, spinal cord compression, or carcinomatous meningitis.
  • Patient of child-bearing potential is pregnant (eg, positive human chorionic gonadotropin test) or is breast feeding.
  • Patient of child-bearing potential is not willing to use adequate contraceptive precautions.
  • Known active infection, or on antiretroviral therapy for HIV disease.
  • Known positive test for chronic hepatitis B or C infection.
  • Any other underlying physical or mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
  • Refusal or inability to give informed consent to participate in the study.
  • Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study

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
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: A
Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.
의약품: AMG 479 Placebo
Matching placebo administered Day 1 of each 21 day cycle.
실험적: B
AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.
의약품: AMG 479
Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death.
기간: Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle

A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:

  • Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR
  • Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR
  • CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart
Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle

2차 결과 측정

결과 측정
측정값 설명
기간
Time To Progression (TTP): Interval From the Date of Randomization to the Date of Disease Progression
기간: Radiological tumor assessment: every 12 (+/- 1) weeks for 3 years after randomization + CA125: day 1 of each cycle

A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:

  • Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR
  • Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR
  • CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart
Radiological tumor assessment: every 12 (+/- 1) weeks for 3 years after randomization + CA125: day 1 of each cycle
Overall Survival (OS)
기간: Day 1 of each cycle up to 4 years after randomization
Interval between the date from randomization to death from any cause whichever came first.
Day 1 of each cycle up to 4 years after randomization

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Translational Research in Oncology

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

2009년 1월 1일

기본 완료 (실제)

2013년 9월 1일

연구 완료 (실제)

2014년 11월 1일

연구 등록 날짜

최초 제출

2008년 7월 17일

QC 기준을 충족하는 최초 제출

2008년 7월 17일

처음 게시됨 (추정)

2008년 7월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 1월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 12월 8일

마지막으로 확인됨

2015년 12월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TRIO 014

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