Combination Chemotherapy for Metastatic Breast Cancer
2009年11月9日 更新者：Eli Lilly and Company
Phase II Study of Gemcitabine Plus Cisplatin as First-line Treatment of Metastatic Breast Cancer
The purpose of this study is to determine the objective tumor response of the first-line therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer
調査の概要
研究の種類
介入
入学 (実際)
70
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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Munich、ドイツ、81377
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9AM to 5PM Eastern time (UTC/ GMT - 5hours, EST), or speak with your personal physician
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Moscow、ロシア連邦、115478
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9AM to 5PM Eastern time (UTC/ GMT - 5hours, EST), or speak with your personal physician
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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～75年 (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
女性
説明
Inclusion Criteria:
- You are female in the age of 18 to 75 years old.
- You have been diagnosed with the metastatic breast cancer.
- You have desire and an opportunity to visit your doctor in medical site, both during realization of the active treatment program, and within 24 months of medical follow up.
- You must sign this informed consent form
Exclusion Criteria:
- You are pregnant or breastfeeding.
- Your laboratory parameters fall outside the limits, admitted by requirements of the present clinical study.
- You have been diagnosed with serious concomitant or acute infectious disease.
- You have used experimental medications within the last month.
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：Gemcitabine + Cisplatin
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Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 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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Objective Tumor Response
時間枠：baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.)
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Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
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baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 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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Duration of Response
時間枠：first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
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The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
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first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
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Time to Progressive Disease
時間枠：first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
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Defined as the time from study enrollment to the first date of disease progression.
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first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
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Time to Treatment Failure
時間枠：first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
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Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment.
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first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
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Survival Time
時間枠：first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
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Overall survival is the duration from enrollment to death due to any cause.
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first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
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Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
時間枠：Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)
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The CTC provides descriptive terminology for adverse event reporting.
A grading (severity) scale is provided for each adverse event term.
Grades range from 0 (none) to 5 (death).
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Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)
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Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
時間枠：Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)
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Maximum CTC-NCI toxicity grade for hematology.
Grades range from 0 (none) to 5 (death).
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Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)
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Number of Deaths
時間枠：Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
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Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
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Number of Participants With Adverse Events Leading to Discontinuation
時間枠：Baseline through eight 21-day cycles
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Baseline through eight 21-day cycles
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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
捜査官
- スタディディレクター：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST),、Eli Lilly and Company
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
2002年10月1日
研究の完了 (実際)
2007年10月1日
試験登録日
最初に提出
2005年9月12日
QC基準を満たした最初の提出物
2005年9月12日
最初の投稿 (見積もり)
2005年9月19日
学習記録の更新
投稿された最後の更新 (見積もり)
2009年11月11日
QC基準を満たした最後の更新が送信されました
2009年11月9日
最終確認日
2009年11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。