Bortezomib in Treating Patients With Malignant Pleural Mesothelioma
An Open Label Phase II Multicentre Clinical Trial of Single Agent Bortezomib in Patients With Malignant Pleural Mesothelioma
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects of bortezomib and how well it works in treating patients with malignant pleural mesothelioma.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Assess the clinical efficacy of bortezomib based on the evaluation of objective tumor response rate.
Secondary
- Assess additional clinical efficacy of bortezomib based on the evaluation of time to early disease progression and median overall 2-year survival rate.
- Assess safety and toxicity in these patients.
- Assess quality of life using the Lung Cancer Symptom Score.
OUTLINE: This is a multicenter study. Patients are stratified according to current treatment (first-line vs second-line)
Patients receive bortezomib IV on days 1, 8, 15, and 22. Treatment repeats every 5 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients exhibiting objective response or stable disease by week 20, may continue treatment at the discretion of the investigator until evidence of disease progression.
Quality of life is assessed periodically.
After completion of study treatment, patients are followed for up to 2 years.
PROJECTED ACCRUAL: 57 first-line setting and 54 second-line setting patients will be accrued for this study.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Amsterdam, 네덜란드, 1066 BE
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
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Ghent, 벨기에, B-9000
- Universitair Ziekenhuis Gent
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Cork, 아일랜드
- Cork University Hospital
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Dublin, 아일랜드, 9
- Beaumont Hospital
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Dublin, 아일랜드, 7
- Mater Misericordiae University Hospital
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Dublin, 아일랜드, 4
- St. Vincent's University Hospital
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Dublin, 아일랜드, 24
- Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
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Dublin, 아일랜드, 8
- St. James's Hospital
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Galway, 아일랜드
- Galway University Hospital
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England
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London, England, 영국, EC1A 7BE
- Saint Bartholomew's Hospital
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Sutton, England, 영국, SM2 5PT
- Royal Marsden - Surrey
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Northern Ireland
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Belfast, Northern Ireland, 영국, BT9 7BL
- Centre for Cancer Research and Cell Biology at Queen's University Belfast
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Scotland
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Glasgow, Scotland, 영국, G11 6NT
- Beatson West of Scotland Cancer Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Inclusion criteria:
- Histologically confirmed malignant pleural mesothelioma
Meets 1 of the following criteria for first-line or second-line chemotherapy:
- Patients in the first-line setting must be unsuitable for, cannot access locally, or refuse combination chemotherapy
Patients in the second-line setting must be unsuitable for, cannot access locally, or refuse cytotoxic chemotherapy after failure of a first-line regimen
- Second-line patients may not have received more than 1 prior line of antineoplastic treatment for this cancer
Pleural effusions should be drained before treatment whenever possible
- Talc or tetracycline pleurodesis may be used per standard practice for uncontrollable pleural effusions (recurrent despite regular drainage)
Exclusion criteria:
- Symptomatic or known brain or leptomeningeal metastases
PATIENT CHARACTERISTICS:
Inclusion criteria:
- ECOG performance status 0-2
- Hemoglobin ≥ 10 g/dL
- Neutrophil count ≥ 1,500 mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine clearance ≥ 30 mL/min
- AST and ALT < 3 times upper limit of normal
- Fertile patients must use effective contraception during study therapy
Exclusion criteria:
- Pregnant or breastfeeding
- History of prior malignant tumor within the past 3 years except for nonmelanoma skin tumor or carcinoma in situ of the cervix
- Patients suitably fit to receive a platinum doublet based chemotherapy (first-line only)
Uncontrolled or severe cardiovascular disease including any of the following:
- Myocardial infarction within the past 6 months
- New York Heart Association class III or IV heart failure
- Uncontrolled angina
- Clinically significant pericardial disease
- Cardiac amyloidosis
- Neuropathy ≥ grade 2 OR grade 1 with pain
- Serious medical (e.g., uncontrolled diabetes, hepatic disease, or infection) or psychiatric illness that would interfere with study participation
- Patients with known HIV or hepatitis B or C infection
PRIOR CONCURRENT THERAPY:
- No prior bortezomib
- No prior extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks before enrollment
- No preplanned surgery or procedures that would interfere with the study
More than 4 weeks since enrollment in another therapeutic clinical trial (i.e., received an experimental drug or used an experimental medical device)
- Concurrent participation in non-treatment studies is allowed provided they do not interfere with participation in this study
No concurrent experimental or antineoplastic agent other than bortezomib
- Medications that may have antineoplastic activity, but are taken for other reasons than specific antineoplastic effect (e.g., megestrol [Megace®], cyclo-oxygenase-2 [COX-2] inhibitors, or bisphosphonates) are allowed
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Bortezomib 1.6mg/m2
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Objective tumor response rate (complete response or partial response) as assessed by modified RECIST criteria
기간: 28 days prior to baseline, at 10 weeks and at end of treatment
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The objective tumour response rate is a primary endpoint of the study.
This will be a proportion of evaluable subjects who achieve a confirmed CR or PR per modified RECIST guidelines within four cycles (20 weeks) of treatment.
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28 days prior to baseline, at 10 weeks and at end of treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time to disease progression
기간: Time to disease progression is measured from first treatment until the date of PD or death whichever is first reported. Subjects who did not progress or die will be censored at the day of their last tumour assessment.
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Time to disease progression is measured from first treatment until the date of PD or death whichever is first reported. Subjects who did not progress or die will be censored at the day of their last tumour assessment.
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Overall survival
기간: Overall Survival is measured from the date of first treatment to the date of the subject's death. If the subject is alive or the vital status is unknown, the date of death will be censored at the date that the subject is last known to be alive.
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Overall Survival is measured from the date of first treatment to the date of the subject's death. If the subject is alive or the vital status is unknown, the date of death will be censored at the date that the subject is last known to be alive.
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Safety
기간: The assessment of safety will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of the pre-determined normal ranges.
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The assessment of safety will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of the pre-determined normal ranges.
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Quality of life
기간: Week 1, Week 10 and end of treatment
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Quality of life will be assessed using the Lung Cancer Symptom Score
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Week 1, Week 10 and end of treatment
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dean A. Fennell, MD, PhD, Centre for Cancer Research and Cell Biology at Queen's University Belfast
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 05-10 ICORG
- ICORG-05-10
- EUDRACT-2005-004420-39
- EU-20748
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삶의 질 평가에 대한 임상 시험
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Memorial Sloan Kettering Cancer Center종료됨
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Rostyslav Voloshchuk아직 모집하지 않음전신 마취 | 확인 | 수술 후 회복 | 설문지