A Study of Bevacizumab (Avastin) in Combination With Dacarbazine in Participants With Unresectable/Metastatic Melanoma
2017年3月10日 更新者：Hoffmann-La Roche
Phase II Study of Dacarbazine With the Anti-Vascular Endothelial Growth Factor Antibody (Bevacizumab) in Patients With Unresectable/Metastatic Melanoma
This study will assess the preliminary anti-tumor activity and safety profile of a combination of bevacizumab and dacarbazine in participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease.
調査の概要
研究の種類
介入
入学 (実際)
40
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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Lombardia
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Milano、Lombardia、イタリア、20141
- Istituto Europeo di Oncologia
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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:
- Histologically or cytologically confirmed cutaneous malignant melanoma
- Clinical evidence of metastatic disease and/or unresectable regional lymphatic disease and/or extensive in transit recurrent disease
- Measurable and/or evaluable lesions according to RECIST
Exclusion Criteria:
- Prior interferon alfa and/or cytokine therapy for metastatic disease
- Prior chemotherapy for metastatic disease
- Brain metastases
- Chronic daily treatment with high-dose aspirin (more than 325 milligrams per day)
- Other co-existing malignancies or malignancies diagnosed within the past 5 years with the exception of basal cell cancer or cervical cancer in situ
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：なし
- 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：Dacarbazine + Bevacizumab
Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease will receive dacarbazine and bevacizumab until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
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Bevacizumab will be given as 10 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Days 1 and 14 of each 28-day cycle.
他の名前：
Dacarbazine will be given as 800 milligrams per square meter (mg/m^2) via IV infusion on Day 1 of each 28-day cycle.
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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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Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)
時間枠：Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
|
Tumor assessments were performed using RECIST.
CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers.
PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to sum of LD at Baseline.
Both were to be confirmed at a follow-up visit at least 4 weeks from the initial assessment of CR or PR.
The percentage of participants with a best overall response of CR or PR during the study was reported.
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Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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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 Death or Disease Progression Following a Previous Assessment of CR or PR According to RECIST
時間枠：Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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Tumor assessments were performed using RECIST.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s).
CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
The percentage of participants who died or demonstrated disease progression among those with a previous assessment of CR or PR was reported.
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Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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Duration of Response (DOR) With CR or PR According to RECIST
時間枠：Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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Tumor assessments were performed using RECIST.
DOR was defined as the time from first assessment of CR or PR to the time of death or disease progression, whichever occurred first.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s).
CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
DOR was estimated by Kaplan-Meier methodology and expressed in months.
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Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR, PR, or Stable Disease (SD) According to RECIST
時間枠：Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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Tumor assessments were performed using RECIST.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s).
CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression, using smallest sum of LD on study as reference.
The percentage of participants who died or demonstrated disease progression among those with a previous assessment of CR, PR, or SD was reported.
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Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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DOR With CR, PR, or SD According to RECIST
時間枠：Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
|
Tumor assessments were performed using RECIST.
DOR was defined as the time from first assessment of CR, PR, or SD to the time of death or disease progression, whichever occurred first.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s).
CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression, using smallest sum of LD on study as reference.
DOR was estimated by Kaplan-Meier methodology and expressed in months.
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Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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Percentage of Participants With Death or Disease Progression According to RECIST
時間枠：Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
|
Tumor assessments were performed using RECIST.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s).
The percentage of participants who died or demonstrated disease progression was reported.
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Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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Time to Progression (TTP) According to RECIST
時間枠：Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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Tumor assessments were performed using RECIST.
TTP was defined as the time from Baseline visit to time of death or disease progression, whichever occurred first.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s).
TTP was estimated by Kaplan-Meier methodology and expressed in months.
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Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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Percentage of Participants Who Discontinued Treatment
時間枠：Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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The percentage of participants who discontinued treatment as a result of death, adverse event, disease progression, loss to follow-up, non-compliance, or consent withdrawal was reported.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s).
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Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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Time to Treatment Failure (TTF)
時間枠：Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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TTF was defined as the time from start of treatment to the time of treatment discontinuation as a result of death, adverse event, disease progression, loss to follow-up, non-compliance, or consent withdrawal was reported.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s).
TTF was estimated by Kaplan-Meier methodology and expressed in months.
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Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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Percentage of Participants Who Died
時間枠：Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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The percentage of participants who died from any cause was reported.
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Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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Overall Survival (OS)
時間枠：Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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OS was defined as the time from Baseline visit to the time of death from any cause.
OS was estimated by Kaplan-Meier methodology and expressed in months.
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Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
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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
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 (実際)
2006年6月30日
一次修了 (実際)
2012年5月31日
研究の完了 (実際)
2012年5月31日
試験登録日
最初に提出
2010年7月8日
QC基準を満たした最初の提出物
2010年7月15日
最初の投稿 (見積もり)
2010年7月16日
学習記録の更新
投稿された最後の更新 (実際)
2017年4月21日
QC基準を満たした最後の更新が送信されました
2017年3月10日
最終確認日
2017年3月1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。
Bevacizumabの臨床試験
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Weill Medical College of Cornell University終了しました多形性膠芽腫 | 退形成性星細胞腫 | びまん性内因性橋グリオーマ | 脳幹グリオーマ | 毛包粘液性星細胞腫 | 脳幹の神経膠腫 | 脳の線維性星細胞腫 | 混合乏突起膠腫-星細胞腫アメリカ