A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer
2014年5月7日 更新者：Hoffmann-La Roche
A Single-arm, Open-label Study of Avastin Plus Xeloda on Objective Treatment Response in Patients With Advanced or Metastatic Liver Cancer Who Have Had no Previous Cytotoxic Chemotherapy
This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer.
The anticipated time on study treatment is 3-12 months.
調査の概要
研究の種類
介入
入学 (実際)
45
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。
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;
- advanced or metastatic liver cancer;
- >=1 measurable lesion.
Exclusion Criteria:
- current radiotherapy, chemotherapy, or other experimental therapies;
- prior cytotoxic chemotherapy;
- major surgery, open biopsy, or traumatic injury within 28 days of study entry;
- history of a malignancy during the last 5 years, other than cutaneous basal cell cancer or in situ cervical cancer.
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 |
|---|---|
|
実験的：Avastin + Xeloda
|
7.5mg/kg iv on day 1 of each 3 week cycle.
1600mg/m2/day po in 2 divided doses, on days 1 to 14 of each 3 week cycle.
|
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 |
|---|---|---|
|
Percentage of Participants With Objective Response (OR)
時間枠：Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
|
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response.
The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported.
CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels.
No new lesions.
PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions.
The short axis was used in the sum for target lesions.
Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits.
No new lesions.
|
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants With Disease Control
時間枠：Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
|
The percentage of participants with disease control was based on assessment of confirmed CR, PR, or stable disease (SD) according to RECIST criteria.
Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response.
The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported.
CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels.
No new lesions.
PR was defined as ≥ 30 % decrease under baseline of the sum of diameters of all target lesions.
The short axis was used in the sum for target lesions.
Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits.
No new lesions.
SD was defined as not qualifying for PR or progressive disease.
|
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
|
|
Time to Disease Progression - Percentage of Participants With an Event
時間枠：Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
|
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death.
Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.
|
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
|
|
Time to Disease Progression
時間枠：Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
|
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death.
Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of their tumor assessment.
|
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
|
|
Time to Disease Progression - Percentage of Participants Progression-free at 12 Months
時間枠：Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
|
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death.
Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.
|
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
|
|
Overall Survival - Percentage of Participants With an Event
時間枠：Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
|
Overall Survival was defined as the time in months from randomization to date of death due to any cause.
Participants without an event were censored the last time they were known to be alive.
|
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
|
|
Overall Survival
時間枠：Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
|
Overall Survival was defined as the time in months from randomization to date of death due to any cause.
Participants without an event were censored the last time they were known to be alive.
Median Overall Survival was estimated using the Kaplan-Meier method.
|
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
|
|
Overall Survival - Percentage of Participants Event Free at 12 Months
時間枠：Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
|
Overall Survival was defined as the time in months from randomization to date of death due to any cause.
Participants without an event were censored the last time they were known to be alive.
|
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
|
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
2005年5月1日
一次修了 (実際)
2008年3月1日
研究の完了 (実際)
2008年3月1日
試験登録日
最初に提出
2013年12月3日
QC基準を満たした最初の提出物
2013年12月11日
最初の投稿 (見積もり)
2013年12月17日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年6月6日
QC基準を満たした最後の更新が送信されました
2014年5月7日
最終確認日
2014年5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。