A Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab for Breast Cancer
2016年2月9日 更新者：R-Pharm
A Phase II Open Label, Randomized, 3 Arm Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab as First Line Therapy for Locally Recurrent or Metastatic Breast Cancer
The purpose of this clinical research study is to learn if ixabepilone plus bevacizumab is effective in shrinking or stopping the growth of cancer when given as first-line chemotherapy in participants with metastatic breast cancer.
The study will also assess the safety of this combination treatment.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
136
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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California
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Burbank、California、アメリカ、91505
- East Valley Hematology and Oncology medical Group
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La Verne、California、アメリカ、91750
- Wilshire Oncology Medical Group, Inc.
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San Francisco、California、アメリカ、94115
- Ucsf-Comprehensive Cancer Center
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Iowa
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Iowa City、Iowa、アメリカ、52242
- University of Iowa Hospitals and Clinics
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Missouri
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Columbia、Missouri、アメリカ、65203
- Ellis Fischel Cancer Center
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New York
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New York、New York、アメリカ、10021
- Weill Medical College of Cornell University
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Merseyside、イギリス、CH63 4JY
- Local Institution
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Essex
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Chelmsford、Essex、イギリス、CM1 7ET
- Local Institution
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Greater Manchester
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Manchester、Greater Manchester、イギリス、M20 4BX
- Local Institution
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Nottinghamshire
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Nottingham、Nottinghamshire、イギリス、NG5 1PB
- Local Institution
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Cuneo、イタリア、12100
- Local Institution
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Meldola Fc、イタリア、47014
- Local Institution
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Milano、イタリア、20132
- Local Institution
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Modena、イタリア、41100
- Local Institution
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Napoli、イタリア、80131
- Local Institution
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Roma、イタリア、00161
- Local Institution
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Hospitalet De Llobregat、スペイン、08907
- Local Institution
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Jaen、スペイン、23007
- Local Institution
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Besancon Cedex、フランス、25030
- Local Institution
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Clermont-Ferrand、フランス、63000
- Local Institution
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Marseille Cedex 9、フランス、13273
- Local Institution
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Paris Cedex 10、フランス、75475
- Local Institution
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Saint Herblain、フランス、44805
- Local Institution
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Strasbourg Cedex、フランス、67085
- Local Institution
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Tours Cedex、フランス、37044
- Local Institution
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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:
- Locally recurrent or metastatic breast cancer, previously untreated with chemotherapy for advanced disease.
- At least 1 target lesion per RECIST criteria. Locally recurrent disease must not be amenable to resection with curative intent.
- No previous cytotoxic chemotherapy for locally recurrent/metastatic disease.
- Relapse 12 months or more after completing prior adjuvant or neoadjuvant taxane therapy.
- No previous breast cancer known to overexpress or amplify the human epidermal growth factor receptor 2 gene.
- Prior hormonal therapy in adjuvant, recurrent, or metastatic setting allowed but must have been discontinued at least 2 weeks before randomization.
- Karnofsky performance status of 80 to 100 or Eastern Cooperative Oncology Group performance status of 0 to 1.
- Estimated life expectancy of at least 12 weeks.
- Recovery from recent therapy (except for alopecia), including chemotherapy, immunotherapy, biologic therapy, or investigational product. Any such therapy must have been completed at least 3 weeks before randomization and at least 6 weeks from use of nitrosourea, or mitomycin.
- Recovery from recent surgery and radiation therapy. At least 1 week since minor surgery and/or focal/palliative radiation therapy; at least 3 weeks from radiation; at least 4 weeks from major surgery; and at least 8 weeks from liver resection, thoracotomy, or neurosurgery.
- Absolute neutrophil count ≥1500/mm^3.
- Hemoglobin ≥9 g/dL.
- Platelets ≥100,000/mm^3.
- Total bilirubin ≤1.5 times the upper limit of normal (ULN).
- Aspartate aminotransferase or alanine aminotransferase ≤2.5*ULN.
- Normal partial thromboplastin time and either international normalized ratio or prothrombin time <1.5*ULN.
- Serum creatinine ≤1.5*ULN or 24-hour creatinine clearance >60 mL/min.
- Urine dipstick for proteinuria <2+ (negative, trace, or +1). Participants with ≥2+ proteinuria at baseline were to undergo 24-hour urine collection and demonstrate ≤1g of protein in 24 hours to be eligible.
Exclusion criteria:
- Women of child-bearing potential (WOCBP) unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 6 months after treatment with bevacizumab.
- Women who were pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- Sexually active fertile men, whose partners were WOCBP, not using an adequate method of birth control.
- Evidence of baseline sensory or motor neuropathy.
- Serious infection or nonmalignant medical illnesses uncontrolled or the control of which could be jeopardized by this therapy.
- History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, serious gastric ulcer, or bone fracture within 6 months of study entry.
- History of hypertensive crisis or hypertensive encephalopathy.
- Significant vascular disease.
- Clinically significant cardiovascular disease.
- Baseline left ventricular ejection fraction by multiple-gated acquisition scan or echocardiogram for subjects with prior exposure to anthracyclines not within institutional normal limits.
- Symptomatic peripheral vascular disease.
- History of high dose chemotherapy with bone marrow transplant or peripheral blood stem cell transplant within the previous 2 years.
- Evidence of bleeding diathesis or coagulopathy.
- Prior treatment with an epothilone or any antiangiogenic agent.
- Concurrent nonhealing wound, ulcer, or fracture.
- Any current or history of brain and/or leptomeningeal metastases. Psychiatric disorders or other conditions rendering the participant incapable of complying with the requirements of the protocol.
- Any concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix.
- Known allergy to any of the study drugs or their excipients.
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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実験的：Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg
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Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks.
Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose.
Then if still tolerated, over 30 minutes for subsequent infusions.
Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
他の名前：
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実験的：Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg
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Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity (After Cycle 4, dose reduction to 32 mg/m^2 was to be implemented for all subsequent cycles.)
Bevacizumab, 15 mg/kg, administered as IV infusion every 3 weeks.
Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose.
Then if still tolerated, over 30 minutes for subsequent infusions.
Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
他の名前：
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アクティブコンパレータ：Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg
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Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks.
Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose.
If still tolerated, over 30 minutes for subsequent infusions.
Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
他の名前：
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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 Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study
時間枠：Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression
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CR=Disappearance of all clinical and radiologic evidence of target lesions; PR=At least 30% reduction in the sum of the longest diameter of all target lesions.
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Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression
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Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
時間枠：Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression
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Best tumor response was assessed with RECIST.
Complete response (CR)=Disappearance of all evidence of target lesions; Partial response (PR)=At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions; Progressive disease (PD)=At least a 20% increase from baseline in the sum of LD of target lesions or the appearance of 1 or more new lesions; Stable disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
A response was confirmed if noted on 2 examinations at least 4 weeks apart.
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Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression
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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 Progression-free Survival at Week 24
時間枠：Date of randomization to Week 24
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Week 24 Progression-free Survival was defined as the number of participants who neither progressed nor died before Week 24.
Computed using Kaplan-Meier estimates, only at the time of Interim Analysis, when all participants had been followed for 6 months.
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Date of randomization to Week 24
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Median Progression-free Survival (PFS)
時間枠：Date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 29 months)
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PFS was defined as the time from randomization to progression or to death from any cause without prior documentation of progression.
Participants who did not progress or die were to be censored on the date of their last tumor assessment.
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Date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 29 months)
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Median Time to Response
時間枠：Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant time to response of 67 weeks)
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Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for a PR or CR, whichever was recorded first.
Time to response was computed only for participants whose best response was PR or CR.
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Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant time to response of 67 weeks)
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Median Duration of Response
時間枠：Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 25 weeks)
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Duration of response was computed for participants whose best response was either PR or CR.
Duration of overall response was defined as the period from the time that measurement criteria were first met for PR or CR, whichever was recorded first, until the first date of documented PD or death.
Participants who neither relapsed nor died were to be censored on the date of their last tumor assessment.
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Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 25 weeks)
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Percentage of Participants Surviving at 1 Year
時間枠：Date first participant enrolled to 1 year
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One year survival rates were computed using Kaplan-Meier estimates.
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Date first participant enrolled to 1 year
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Number of Participants With Death as Outcome, Serious Adverse Events (SAEs) Treatment-related SAEs, Treatment-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, Treatment-related AEs
時間枠：At initiation of treatment throughout study, to a minimum of 30 days after last dose of study drug
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An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment.
An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization.
Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
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At initiation of treatment throughout study, to a minimum of 30 days after last dose of study drug
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Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade
時間枠：At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle
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CTC, Version 3 used to assess parameters.
CTC Gr=Grade; WBC=white blood cells; ANC=absolute neutrophil count.
LLN=lower level of normal.
WBC Gr 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L;
ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L;
Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L; Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.
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At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle
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Number of Participants With Abnormalities in Liver Function by Worst CTC Grade
時間枠：At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle
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ULN=Upper limit of normal.ALT Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN;
AST Gr 1: >ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN;
ALP Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN;
Total bilirubin Gr 1: >ULN to 1.5*ULN, Gr 2: >1.5 to 3.0*ULN, Gr 3: >3.0 to 10.0*ULN, Gr 4: >10.0*ULN.
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At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle
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Number of Participants With Abnormalities in Renal Function by Worst CTC Grade
時間枠：At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle
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Creatine Gr 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.
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At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle
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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
2007年3月1日
一次修了 (実際)
2009年11月1日
研究の完了 (実際)
2009年11月1日
試験登録日
最初に提出
2006年8月30日
QC基準を満たした最初の提出物
2006年8月30日
最初の投稿 (見積もり)
2006年8月31日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年3月10日
QC基準を満たした最後の更新が送信されました
2016年2月9日
最終確認日
2016年2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。
転移性乳がんの臨床試験
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Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated... と他の協力者完了
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Novartis Pharmaceuticals終了しましたメラノーマ | 高度なEGFR変異体非小さな細胞肺cancer（NSCLC） | KRAS G12変異NSCLC | 食道扁平上皮がん（SCC） | ヘッド/ネックSCC | 進行した胃腸間質腫瘍（GIST） | 進行したNRAS/BRAFT WT皮膚黒色腫アメリカ, 台湾, オランダ, カナダ, スペイン, シンガポール, イタリア, 日本, 韓国
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kgの臨床試験
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Children's Hospital Medical Center, CincinnatiSobi, Inc.募集
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University of Ioannina募集
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Rockefeller UniversityBrigham and Women's Hospital; Weill Medical College of Cornell University; University of Cologne完了
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Chengdu Zenitar Biomedical Technology Co., Ltd積極的、募集していない