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Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

2018년 6월 27일 업데이트: Gynecologic Oncology Group

A Randomized Phase II Evaluation of Topotecan (NSC #609699) Administered Daily x 5 Every 3 Weeks vs Weekly Topotecan in the Treatment of Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving topotecan in different dosing schedules may kill more tumor cells.

PURPOSE: This phase II trial is studying how well topotecan works in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

OBJECTIVES:

Primary

  • Determine the antitumor activity of topotecan, in terms of frequency and duration of tumor response, in patients with recurrent platinum-sensitive ovarian epithelial, fallopian tube, or primary peritoneal cancer.
  • Determine the nature and degree of toxicity of this regimen in these patients.

Secondary

  • Determine the duration of progression-free survival and overall survival in patients treated with these regimens.
  • Determine the effects of prognostic variables (i.e., initial performance status, age, and mucinous or clear cell histology) in patients treated with these regimens.

OUTLINE: This is a multicenter study.

Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 38-110 patients (19-55 per treatment arm) will be accrued for this study within 15-30 months.

연구 유형

중재적

등록 (실제)

81

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 미국
    • Connecticut
      • Hartford, Connecticut, 미국, 06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
      • New Britain, Connecticut, 미국, 06050
        • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
    • Delaware
      • Lewes, Delaware, 미국, 19958
        • Tunnell Cancer Center at Beebe Medical Center
      • Newark, Delaware, 미국, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, 미국, 20010
        • Washington Cancer Institute at Washington Hospital Center
    • Georgia
      • Augusta, Georgia, 미국, 30912
        • MBCCOP - Medical College of Georgia Cancer Center
    • Illinois
      • Aurora, Illinois, 미국, 60507
        • Rush-Copley Cancer Care Center
      • Chicago, Illinois, 미국, 60612
        • Rush University Medical Center
      • Chicago, Illinois, 미국, 60612-7243
        • University of Illinois Cancer Center
      • Hinsdale, Illinois, 미국, 60521
        • Hinsdale Hematology Oncology Associates
      • Joliet, Illinois, 미국, 60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Park Ridge, Illinois, 미국, 60068-1174
        • Advocate Lutheran General Cancer Care Center
      • Urbana, Illinois, 미국, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, 미국, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Michigan City, Indiana, 미국, 46360
        • Saint Anthony Memorial Health Centers
    • Iowa
      • Iowa City, Iowa, 미국, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
    • Louisiana
      • Baton Rouge, Louisiana, 미국, 70815
        • Woman's Hospital
    • Maryland
      • Elkton, Maryland, 미국, 21921
        • Union Hospital Cancer Program at Union Hospital
    • Massachusetts
      • Boston, Massachusetts, 미국, 02111
        • Tufts-NEMC Cancer Center
      • Worcester, Massachusetts, 미국, 01655
        • UMASS Memorial Cancer Center - University Campus
    • Michigan
      • Ann Arbor, Michigan, 미국, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, 미국, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Dearborn, Michigan, 미국, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Flint, Michigan, 미국, 48503
        • Hurley Medical Center
      • Flint, Michigan, 미국, 48503
        • Genesys Hurley Cancer Institute
      • Grosse Pointe Woods, Michigan, 미국, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Jackson, Michigan, 미국, 49201
        • Foote Memorial Hospital
      • Kalamazoo, Michigan, 미국, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, 미국, 49001
        • Borgess Medical Center
      • Kalamazoo, Michigan, 미국, 49007-3731
        • West Michigan Cancer Center
      • Lansing, Michigan, 미국, 48912-1811
        • Sparrow Regional Cancer Center
      • Livonia, Michigan, 미국, 48154
        • St. Mary Mercy Hospital
      • Pontiac, Michigan, 미국, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, 미국, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Royal Oak, Michigan, 미국, 48073
        • William Beaumont Hospital - Royal Oak Campus
      • Saginaw, Michigan, 미국, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • Warren, Michigan, 미국, 48093
        • St. John Macomb Hospital
    • Mississippi
      • Jackson, Mississippi, 미국, 39216
        • University of Mississippi Cancer Clinic
    • Missouri
      • Saint Louis, Missouri, 미국, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
      • Saint Louis, Missouri, 미국, 63110
        • Saint Louis University Cancer Center
      • Springfield, Missouri, 미국, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, 미국, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, 미국, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Nebraska
      • Lincoln, Nebraska, 미국, 68510
        • Cancer Resource Center - Lincoln
      • Omaha, Nebraska, 미국, 68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha, Nebraska, 미국, 68114
        • Methodist Estabrook Cancer Center
    • New Jersey
      • Neptune, New Jersey, 미국, 07754-0397
        • Jersey Shore Cancer Center at Jersey Shore University Medical Center
      • Voorhees, New Jersey, 미국, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New York
      • Brooklyn, New York, 미국, 11203
        • SUNY Downstate Medical Center
      • New York, New York, 미국, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
      • Stony Brook, New York, 미국, 11794-9446
        • Stony Brook University Cancer Center
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, 미국, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Winston-Salem, North Carolina, 미국, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Akron, Ohio, 미국, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Cleveland, Ohio, 미국, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, 미국, 44106-5065
        • Case Comprehensive Cancer Center
      • Cleveland, Ohio, 미국, 44111
        • Cleveland Clinic Cancer Center at Fairview Hospital
      • Columbus, Ohio, 미국, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, 미국, 43222
        • Mount Carmel Health - West Hospital
      • Mayfield Heights, Ohio, 미국, 44124
        • Hillcrest Cancer Center at Hillcrest Hospital
      • Mentor, Ohio, 미국, 44060
        • Lake/University Ireland Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73104
        • Oklahoma University Cancer Institute
      • Tulsa, Oklahoma, 미국, 74104
        • Cancer Care Associates - Midtown Tulsa
    • Pennsylvania
      • Abington, Pennsylvania, 미국, 19001
        • Rosenfeld Cancer Center at Abington Memorial Hospital
      • Bryn Mawr, Pennsylvania, 미국, 19010
        • Bryn Mawr Hospital
      • Hershey, Pennsylvania, 미국, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Paoli, Pennsylvania, 미국, 19301-1792
        • Cancer Center of Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, 미국, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Reading, Pennsylvania, 미국, 19612-6052
        • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
      • Wynnewood, Pennsylvania, 미국, 19096
        • CCOP - MainLine Health
      • Wynnewood, Pennsylvania, 미국, 19096
        • Lankenau Cancer Center at Lankenau Hospital
    • South Dakota
      • Sioux Falls, South Dakota, 미국, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, 미국, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Texas
      • Amarillo, Texas, 미국, 79106
        • Harrington Cancer Center
    • Wisconsin
      • Marshfield, Wisconsin, 미국, 54449
        • Marshfield Clinic - Marshfield Center
      • Rice Lake, Wisconsin, 미국, 54868
        • Marshfield Clinic - Indianhead Center
      • Weston, Wisconsin, 미국, 54476
        • Marshfield Clinic - Weston Center

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer

    • Recurrent disease

  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

    • At least 1 target lesion not in a previously irradiated field

  • Received 1, and only 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 have not received prior paclitaxel may receive a second regimen that includes paclitaxel

  • Platinum-sensitive disease

    • Treatment-free interval* without clinical evidence of progressive disease for > 6 months after prior response to a platinum-based regimen NOTE: *Non-platinum maintenance or consolidation therapy is not included in calculation of the treatment-free interval
  • 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
  • Creatinine clearance > 40 mL/min

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No sensory or motor neuropathy > grade 1
  • No active infection requiring antibiotics
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 3 weeks since prior biologic or immunologic agents for the malignancy
  • No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small molecule inhibitors of signal transduction) for recurrent disease
  • No concurrent cytokines during the first course of study treatment
  • No concurrent pegfilgrastim

Chemotherapy

  • See Disease Characteristics
  • See Biologic therapy
  • Recovered from prior chemotherapy
  • No other prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimen
  • No prior topotecan

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 marrow-bearing areas

Surgery

  • Recovered from prior surgery

Other

  • At least 3 weeks since other prior therapy for the malignancy
  • No prior anticancer therapy that would preclude study treatment

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: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle
Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle until disease progression or adverse effects prohibit further therapy
의약품: 토포테칸 염산염
활성 비교기: Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28 day cycle
Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28 day cycle until disease progression or adverse effects prohibit further therapy
의약품: 토포테칸 염산염

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Objective Tumor Response
기간: Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal

Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):

Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.

Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.

Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.

Stable Disease is any condition not meeting the above criteria.

Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.
Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
기간: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up

2차 결과 측정

결과 측정
기간
Reason Off Study Therapy
기간: study entry through end of study treatment, up to 5 years
study entry through end of study treatment, up to 5 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Gynecologic Oncology Group

협력자

National Cancer Institute (NCI)

수사관

  • 연구 의자: Thomas J. Herzog, MD, Herbert Irving Comprehensive Cancer Center

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

2005년 1월 1일

기본 완료 (실제)

2011년 1월 1일

연구 등록 날짜

최초 제출

2005년 6월 13일

QC 기준을 충족하는 최초 제출

2005년 6월 13일

처음 게시됨 (추정)

2005년 6월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 7월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 6월 27일

마지막으로 확인됨

2014년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GOG-0146Q
  • CDR0000434848

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. .

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