A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer
2014年11月25日 更新者：Hoffmann-La Roche
A Randomized, Open-label Study of the Effect of Omnitarg in Combination With Carboplatin-based Chemotherapy Versus Carboplatin-based Therapy Alone on Treatment Response in Patients With Platinum-sensitive Recurrent Ovarian Cancer
This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian 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)
149
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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Birmingham、イギリス、B18 7QH
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London、イギリス、W12 OHS
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Manchester、イギリス、M20 4BX
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Plymouth、イギリス、PL6 8DH
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Sutton、イギリス、SM2 5PT
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Yeovil、イギリス、BA21 4AT
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Emilia-Romagna
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Parma、Emilia-Romagna、イタリア、43100
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Lombardia
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Milano、Lombardia、イタリア、20133
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Amsterdam、オランダ、1081 HV
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Amsterdam、オランダ、1066 CX
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Alberta
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Calgary、Alberta、カナダ、T2N 4N2
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British Columbia
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Kelowna、British Columbia、カナダ、V1Y 5L3
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Vancouver、British Columbia、カナダ、V5Z 4E6
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Barcelona、スペイン、08036
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Barcelona、スペイン、08035
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Madrid、スペイン、28041
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Valencia、スペイン、46009
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Budapest、ハンガリー、1122
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Debrecen、ハンガリー、4032
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Gyor、ハンガリー、9024
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Bruxelles、ベルギー、1000
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Leuven、ベルギー、3000
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Wilrijk、ベルギー、2610
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Poznan、ポーランド、60-535
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Warszawa、ポーランド、02-781
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Kazan、ロシア連邦、420029
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Moscow、ロシア連邦、125284
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Moscow、ロシア連邦、105203
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Moscow、ロシア連邦、115478
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Moscow、ロシア連邦、143423
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Moscow、ロシア連邦、117837
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Saint-Petersburg、ロシア連邦、197022
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St Petersburg、ロシア連邦、197758
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Tomsk、ロシア連邦、634028
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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
女性
説明
Inclusion Criteria:
- histologically confirmed ovarian, primary peritoneal, or fallopian tube cancer;
- only 1 previous regimen, which must be platinum-based;
- platinum-sensitive disease which is defined by a progression-free interval of greater than 6 months after completion of platinum-based chemotherapy.
Exclusion Criteria:
- previous radiotherapy;
- previous treatment with an anti-cancer vaccine or any targeted therapy;
- major surgery or traumatic injury within 4 weeks of study;
- history or evidence of central nervous system metastases.
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：ランダム化
- 介入モデル：並列代入
- 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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アクティブコンパレータ：化学療法
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175 mg/m2 IV every 3 weeks for 6 cycles
1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles
Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles
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実験的：Chemotherapy + Pertuzumab
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Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks
175 mg/m2 IV every 3 weeks for 6 cycles
1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles
Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles
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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 Disease Progression or Death
時間枠：Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Disease progression was assessed according to RECIST (Response Evaluation Criteria In Solid Tumors), for participants with measurable disease, or by changes in CA 125 (Cancer Antigen 125) according to GCIG (Gynecologic Cancer Inter Group) for all participants.
Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Progression-Free Survival
時間枠：Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier.
Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants.
Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Kaplan-Meier Probability of No Disease or Progression at 1 Year
時間枠：1 year
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The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.
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1 year
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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 Confirmed Response Based on Combined CA 125 and RECIST Measurements
時間枠：Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Response by tumor measurement occurred if there was documented and confirmed complete response (CR) or partial response (PR).
For all participants, response was assessed by both the RECIST and by CA 125 levels, according to whether the participant had measurable or non-measurable disease at baseline.
Response according to CA 125 levels was defined as at least a 50% reduction from baseline.
The decrease had to be confirmed and maintained for at least 28 days.
The confirmatory sample must have been less than or equal to the previous sample (within an assay variability of 10%).
For overall response, the response categories were "response", "stable disease" and "progressive disease".
Stable disease included 1) stable disease as defined by RECIST for solid tumors and 2) CA 125 levels that had not met the definition of "response" or "progressive disease".
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Duration of Response
時間枠：Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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For participants who achieved a response, the duration of response was defined as the interval between initial documentation of response to the first documentation of disease progression or death.
Participants who responded and did not progress or die while on study or while being followed were censored at the last valid tumor or CA 125 measurement.
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Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year
時間枠：1 year
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1 year
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Percentage of Participants With Disease Progression
時間枠：Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
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Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants.
Participants who did not progress while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
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Time to Progressive Disease
時間枠：Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
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The time to progressive disease is the interval of time from date of first dose of study medication to date of first documentation of progressive disease by either RECIST or CA 125 criteria.
Participants who never progressed while being followed were censored at the last valid tumor measurement or CA 125 measurement.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
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Kaplan-Meier Probability of Being Progression Free at 1 Year
時間枠：1 year
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1 year
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Time To Response
時間枠：Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Time to response was the date of first dose of study medication to the date of the first documentation of response, according to CA 125 criteria for all participants or response according to RECIST criteria for participants with measurable disease.
If response was evaluable by both criteria, then the date of response was for the earlier of the two events.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Percentage of Participants Who Died
時間枠：Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Overall Survival
時間枠：Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Survival was the interval of time from date of first dose of study medication to date of death at any time.
Participants who had not died were censored at the date of last contact when they were known to be alive.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Kaplan-Meier Probability of Being Alive at 1 Year
時間枠：1 year
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1 year
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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
2005年12月1日
一次修了 (実際)
2008年9月1日
研究の完了 (実際)
2008年9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3日
最初の投稿 (見積もり)
2013年12月6日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年12月4日
QC基準を満たした最後の更新が送信されました
2014年11月25日
最終確認日
2014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。
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pertuzumabの臨床試験
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Union Hospital, Tongji Medical College, Huazhong...まだ募集していません胆道がん（BTC） | 第一選択治療