A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).
2015年5月22日 更新者：Hoffmann-La Roche
An Open Label Study of the Effect of First Line Treatment With Avastin (Bevacizumab) in Combination With Low-dose Interferon on Progression-free Survival in Patients With Metastatic Clear Cell Renal Cell Carcinoma.
This single arm study will assess progression free survival, tumor response and safety of Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with metastatic clear cell renal cell carcinoma.
Patients will receive Avastin (10mg/kg iv) every 2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week (t.i.w.).
The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
調査の概要
研究の種類
介入
入学 (実際)
146
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Cambridge、イギリス、CB2 2QQ
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Cardiff、イギリス、CF14 2TL
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Milano、イタリア、20100
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Napoli、イタリア、80131
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Pisa、イタリア、56100
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Tallinn、エストニア、13419
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Tallinn、エストニア、10617
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Tartu、エストニア、50406
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Amstelveen、オランダ、1186 AH
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Eindhoven、オランダ、5623 EJ
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Maastricht、オランダ、6229 HX
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Nijmegen、オランダ、6525 GA
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Larissa、ギリシャ、41 110
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Thessaloniki、ギリシャ、56429
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Thessaloniki、ギリシャ、54639
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Aarau、スイス、5000
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Locarno、スイス、6601
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Zürich、スイス、8063
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Eskilstuna、スウェーデン、63188
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Linkoeping、スウェーデン、58185
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Sundsvall、スウェーデン、85186
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Vaxjo、スウェーデン、35185
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Olomouc、チェコ共和国、775 20
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Praha 2、チェコ共和国、128 08
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Arnsberg、ドイツ、59755
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Augsburg、ドイツ、86156
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Berlin、ドイツ、10117
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Berlin、ドイツ、13055
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Freiburg、ドイツ、79106
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Homburg/Saar、ドイツ、66424
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Leipzig、ドイツ、04103
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München、ドイツ、81241
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Münster、ドイツ、48149
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Offenburg、ドイツ、77652
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Planegg、ドイツ、82152
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Stuttgart、ドイツ、70174
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Weiden、ドイツ、92637
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Seinäjoki、フィンランド、60220
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Turku、フィンランド、20520
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Kaunas、リトアニア、50009
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Vilnius、リトアニア、08661
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Barnaul、ロシア連邦、656049
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Ekaterinburg、ロシア連邦、620102
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Moscow、ロシア連邦、125284
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Moscow、ロシア連邦、115478
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Moscow、ロシア連邦、117837
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Obninsk、ロシア連邦、249020
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St Petersburg、ロシア連邦
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UFA、ロシア連邦、450054
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Ulyanovsk、ロシア連邦、432063
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- adult patients, >=18 years of age;
- metastatic RCC with majority (>50%) of conventional clear-cell type;
- prior total nephrectomy for primary RCC;
- at least one measurable or non-measurable lesions;
- ECOG performance score of 0 or 2.
Exclusion Criteria:
- prior systemic treatment for metastatic RCC;
- current or previously treated but non-stable CNS metastases or spinal cord compression;
- major surgery (including open biopsy) or radiation therapy within 28 days prior to enrollment;
- significant cardiovascular disease within 6 months prior to enrollment.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：1
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10mg/kg iv infusion every 2 weeks
3 MIU sc t.i.w.
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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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Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months
時間枠：12 and 24 months
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PFS at 12 and 24 months is an estimate of the percentages of participants expected to be progression free at 12 and 24 months based on Kaplan-Meier survival analysis of the PFS data.
PFS was defined as the time period from the first postbaseline tumor assessment to evidence of disease progression or death from any cause, whichever occurred first.
Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason.
Censoring at start of any subsequent antineoplastic therapy was not performed.
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12 and 24 months
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PFS - Percentage of Participants With an Event
時間枠：Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
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PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first.
Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason.
Censoring at start of any subsequent antineoplastic therapy was not performed.
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Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
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PFS - Time to Event
時間枠：Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
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PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first.
Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason.
Censoring at start of any subsequent antineoplastic therapy was not performed.
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Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
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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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Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR)
時間枠：Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
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Percentage of participants with objective response, termed responders, based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST).
Confirmed responses were those that persisted on repeat imaging study greater than or equal to (≥)4 weeks after initial documentation of response.
CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease.
All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]).
No new lesions.
PR was defined as ≥30 percent (%) decrease under baseline of the sum of diameters of all target lesions.
The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.
No unequivocal progression of non-target disease.
No new lesions.
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Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
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Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months
時間枠：Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
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OS at 12 and 24 months is the estimate of the percentages of participants expected to alive at 12 and 24 months based on Kaplan-Meier survival analysis of the survival data.
Median OS was defined as the time period from the first bevacizumab infusion to death from any cause.
Censoring at start of any subsequent antineoplastic therapy was not performed.
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Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
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OS - Percentage of Participants With an Event
時間枠：Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
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OS was defined as the time period from the first bevacizumab infusion to death from any cause.
Censoring at start of any subsequent antineoplastic therapy was not performed.
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Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
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OS - Time to Event
時間枠：Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
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OS was defined as the time period from the first bevacizumab infusion to death from any cause.
Censoring at start of any subsequent antineoplastic therapy was not performed.
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Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
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Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit
時間枠：Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and End of Treatment (EOT)
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EQ-5D is a standardized, participant-administered measure of health outcome.
It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best).
Answers from the questionnaire for each dimension (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) was classified into one of 2 categories: 'no problems' or 'any problems', and the percentage of participants in each category was determined.
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Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and End of Treatment (EOT)
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EQ-5D - Visual Analog Scale (VAS)
時間枠：Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and EOT
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EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 millimeters (mm) (best imaginable health state); higher scores indicate a better health state.
Participants were asked to rate their health state and mark the line; the distance from the left edge was recorded.
For change from baseline a negative value represents a worsening in the health state and a positive value represents an improvement in the health state.
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Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and EOT
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年12月1日
一次修了 (実際)
2012年2月1日
研究の完了 (実際)
2012年2月1日
試験登録日
最初に提出
2008年11月21日
QC基準を満たした最初の提出物
2008年11月21日
最初の投稿 (見積もり)
2008年11月24日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年5月27日
QC基準を満たした最後の更新が送信されました
2015年5月22日
最終確認日
2015年5月1日
詳しくは
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