Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
2018년 7월 26일 업데이트: Susana M. Campos, MD, Dana-Farber Cancer Institute
A Phase II Trial of Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
The purpose of this study is to determine the effectiveness of sunitinib on participants with ovarian, fallopian tube or peritoneal cancer.
Sunitinib is a newly discovered drug that may stop cancer cells from growing by blocking the blood supply to the tumor.
연구 개요
상세 설명
This study used a two-stage design to evaluate efficacy of sunitinib based on overall response (OR) defined as complete response (CR) or partial response (PR).
The null and alternative OR rate were 5% and 20%.
If one or more patients enrolled in the stage one cohort (n=17 patients) achieved PR or better than accrual would proceed to stage two (n=18 patients).
There was 42% probability of stopping the trial at stage one if the true OR rate was 5%.
With 35 patients, this design had 85% power to detect the 15% difference in OR rates assuming 2-sided type I error rate of 0.05.
연구 유형
중재적
등록 (실제)
36
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, 미국, 02214
- Massachusetts General Hospital
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Boston, Massachusetts, 미국, 02215
- Beth-Israel Deaconess Medical Center
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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
모두
설명
Inclusion Criteria:
- Histologically or cytologically confirmed epithelial ovarian, fallopian tube or peritoneal cancer
- Recurrent or refractory disease
- Measurable disease, defined by RECIST
- 0 to 3 prior cytotoxic chemotherapy or biologic regimens for metastatic disease
- Adverse events related to prior tumor-specific therapy must have resolved to less than or equal to grade 1 prior to study entry
- Ability to swallow oral medications
- 18 years of age or older
- ECOG Performance status must be 0-2
- Normal organ and marrow function as outlined in the protocol
Exclusion Criteria:
- Receiving systemic therapy less than 14 days prior to starting sunitinib
- Receiving any other investigational agent
- Received prior sunitinib
- Untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on screening CT or MRI scans
- Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- Evidence of a bleeding diathesis. Major surgery or NCI CTCA 3.0 grade 3 or worse hemorrhage within 4 weeks of starting study treatment
- Ongoing cardiac dysrhythmias of NCI CTCAE version 3.0 grade > 2
- Pre-existing thyroid abnormality, with thyroid function tests that cannot be maintained in the normal range with medication
- Prolonged QTc interval on baseline EKG
- Uncontrolled hypertension
- Patients who are taking cytochrome P450 enzyme-inducing antiepileptic drugs, rifampin, theophylline, ketoconazole, or St. John's wort.
- Psychiatric illness or social situations that wold limit compliance with study requirements
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration
- Pregnant women
- Clinical or radiographical evidence of a small bowel obstruction
- Poor oral intake
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: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Sunitinib
Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle.
Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
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다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall Response Rate
기간: Clinical assessments were performed weekly for first 4 weeks and every 2 wks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of trt.
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Best response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR).
Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD.
To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.
PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
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Clinical assessments were performed weekly for first 4 weeks and every 2 wks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of trt.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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16-Week Progression-Free Survival
기간: Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.
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16-week progression-free survival is the probability of patients remaining alive and progression-free at 16-weeks from study entry estimated using Kaplan-Meier methods.
Patients alive and progression-free at last follow-up are censored.
Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target lesions.
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Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.
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Progression-Free Survival
기간: Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.
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Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression.
Patients alive without disease progression are censored at the date of last disease evaluation.
Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Equivocal progression of non-target lesions also qualifies as PD.
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Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Susana M. Campos, MD, Dana-Farber Cancer Institute
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
2008년 9월 1일
기본 완료 (실제)
2012년 5월 1일
연구 완료 (실제)
2013년 2월 1일
연구 등록 날짜
최초 제출
2008년 9월 29일
QC 기준을 충족하는 최초 제출
2008년 10월 6일
처음 게시됨 (추정)
2008년 10월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 8월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 7월 26일
마지막으로 확인됨
2018년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 08-056
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