- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00334893
Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
연구 개요
상세 설명
PRIMARY OBJECTIVES:
I. Determine the frequency of objective response (complete and partial responses) in patients with recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer treated with E7389 (eribulin mesylate).
SECONDARY OBJECTIVES:
II. Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior platinum sensitivity (yes vs no).
Patients receive eribulin mesylate intravenously (IV) over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Dana-Farber Cancer Institute
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New York
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New York, New York, 미국, 10065
- Memorial Sloan-Kettering Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Histologically or cytologically confirmed ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer
Recurrent disease after ≥ 1 prior therapy, meeting 1 of the following criteria:
- Platinum-resistant disease (progression-free interval < 6 months)
- Platinum-sensitive disease (progression-free interval ≥ 6 months)
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mmby conventional techniques OR ≥ 10 mm by spiral CT scan
- No known brain metastasis
- Life expectancy > 2 months
- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- WBC ≥ 3,000/mm^3
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatine normal OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
No prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
- Stage IA or IB endometrial cancer within the past 5 years allowed provided patient is considered disease free
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to E7389
- No HIV positivity
- No ongoing or active infection
- No cardiac arrhythmia
- No unstable angina pectoris
- No symptomatic congestive heart failure
- No psychiatric illness or social situations that would preclude study compliance
- No other uncontrolled intercurrent illness
- See Disease Characteristics
- Recovered from effects of recent surgery, radiotherapy, or chemotherapy
- No more than 2 prior cytotoxic therapies with no more than 1 non platinum, non taxane regimen
- No prior E7389
- More than 14 days since prior hormonal therapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- More than 4 weeks since prior radiotherapy
- No concurrent antitumor hormonal therapy
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
- No granulocyte colony-stimulating factors during the first course of study therapy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Treatment (chemotherapy)
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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주어진 IV
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.
기간: up to a total of a year
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Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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up to a total of a year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Toxicity Profile of Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer
기간: From the time of their first treatment with eribulin mesylate
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Measured by NCI CTCAE Version 4.0.
The 95% confidence intervals should be provided.
Please see adverse events.
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From the time of their first treatment with eribulin mesylate
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공동 작업자 및 조사자
수사관
- 수석 연구원: Martee Hensley, Memorial Sloan Kettering Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NCI-2009-00169 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- P30CA008748 (미국 NIH 보조금/계약)
- N01CM62206 (미국 NIH 보조금/계약)
- MSKCC-06027
- NCI-7431
- CDR0000481534
- 06-027 (기타 식별자: Memorial Sloan-Kettering Cancer Center)
- 7431 (기타 식별자: CTEP)
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