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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Cork、アイルランド
- Cork University Hospital
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Dublin、アイルランド、9
- Beaumont Hospital
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Dublin、アイルランド、7
- Mater Misericordiae University Hospital
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Dublin、アイルランド、4
- St. Vincent's University Hospital
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Dublin、アイルランド、24
- Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
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Dublin、アイルランド、8
- St. James's Hospital
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Galway、アイルランド
- Galway University Hospital
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England
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London、England、イギリス、EC1A 7BE
- Saint Bartholomew's Hospital
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Sutton、England、イギリス、SM2 5PT
- Royal Marsden - Surrey
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Northern Ireland
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Belfast、Northern Ireland、イギリス、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、イギリス、G11 6NT
- Beatson West of Scotland Cancer Centre
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Amsterdam、オランダ、1066 BE
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
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Ghent、ベルギー、B-9000
- Universitair Ziekenhuis Gent
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Bortezomib 1.6mg/m2
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Objective tumor response rate (complete response or partial response) as assessed by modified RECIST criteria
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Time to disease progression
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Dean A. Fennell, MD, PhD、Centre for Cancer Research and Cell Biology at Queen's University Belfast
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
生活の質の評価の臨床試験
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Hürriyet YılmazMedipol University完了
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Bogomolets National Medical University完了
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Pediatric Clinical Research PlatformUniversity Hospital, Geneva; Swiss Federal Institute of Technology; Hôpital du Valais募集
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Rostyslav Voloshchukまだ募集していません全身麻酔 | 検証 | 術後の回復 | アンケート