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A Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab for Breast Cancer

2016년 2월 9일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

136

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • California
      • Burbank, California, 미국, 91505
        • East Valley Hematology and Oncology medical Group
      • La Verne, California, 미국, 91750
        • Wilshire Oncology Medical Group, Inc.
      • San Francisco, California, 미국, 94115
        • Ucsf-Comprehensive Cancer Center
    • Iowa
      • Iowa City, Iowa, 미국, 52242
        • University of Iowa Hospitals and Clinics
    • Missouri
      • Columbia, Missouri, 미국, 65203
        • Ellis Fischel Cancer Center
    • New York
      • New York, New York, 미국, 10021
        • Weill Medical College of Cornell University
  • 스페인
      • Hospitalet De Llobregat, 스페인, 08907
        • Local Institution
      • Jaen, 스페인, 23007
        • Local Institution
  • 영국
      • Merseyside, 영국, CH63 4JY
        • Local Institution
    • Essex
      • Chelmsford, Essex, 영국, CM1 7ET
        • Local Institution
    • Greater Manchester
      • Manchester, Greater Manchester, 영국, M20 4BX
        • Local Institution
    • Nottinghamshire
      • Nottingham, Nottinghamshire, 영국, NG5 1PB
        • Local Institution
  • 이탈리아
      • Cuneo, 이탈리아, 12100
        • Local Institution
      • Meldola Fc, 이탈리아, 47014
        • Local Institution
      • Milano, 이탈리아, 20132
        • Local Institution
      • Modena, 이탈리아, 41100
        • Local Institution
      • Napoli, 이탈리아, 80131
        • Local Institution
      • Roma, 이탈리아, 00161
        • Local Institution
  • 프랑스
      • Besancon Cedex, 프랑스, 25030
        • Local Institution
      • Clermont-Ferrand, 프랑스, 63000
        • Local Institution
      • Marseille Cedex 9, 프랑스, 13273
        • Local Institution
      • Paris Cedex 10, 프랑스, 75475
        • Local Institution
      • Saint Herblain, 프랑스, 44805
        • Local Institution
      • Strasbourg Cedex, 프랑스, 67085
        • Local Institution
      • Tours Cedex, 프랑스, 37044
        • Local Institution

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg
의약품: Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg
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.
다른 이름들:
  • BMS-247550
  • 익셈프라
실험적: Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg
의약품: Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg
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.
다른 이름들:
  • BMS-247550
  • 익셈프라
활성 비교기: Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg
의약품: Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg
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.
다른 이름들:
  • 탁솔
  • BMS-181339

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study
기간: Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression
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.
Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression
Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
기간: Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression
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.
Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Progression-free Survival at Week 24
기간: Date of randomization to Week 24
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.
Date of randomization to Week 24
Median Progression-free Survival (PFS)
기간: Date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 29 months)
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.
Date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 29 months)
Median Time to Response
기간: Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant time to response of 67 weeks)
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.
Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant time to response of 67 weeks)
Median Duration of Response
기간: Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 25 weeks)
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.
Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 25 weeks)
Percentage of Participants Surviving at 1 Year
기간: Date first participant enrolled to 1 year
One year survival rates were computed using Kaplan-Meier estimates.
Date first participant enrolled to 1 year
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
기간: At initiation of treatment throughout study, to a minimum of 30 days after last dose of study drug
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.
At initiation of treatment throughout study, to a minimum of 30 days after last dose of study drug
Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade
기간: 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
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.
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
Number of Participants With Abnormalities in Liver Function by Worst CTC Grade
기간: 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
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.
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
Number of Participants With Abnormalities in Renal Function by Worst CTC Grade
기간: 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
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.
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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

R-Pharm

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2007년 3월 1일

기본 완료 (실제)

2009년 11월 1일

연구 완료 (실제)

2009년 11월 1일

연구 등록 날짜

최초 제출

2006년 8월 30일

QC 기준을 충족하는 최초 제출

2006년 8월 30일

처음 게시됨 (추정)

2006년 8월 31일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 3월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 2월 9일

마지막으로 확인됨

2016년 2월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CA163-115

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

전이성 유방암에 대한 임상 시험

Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in United Kingdom

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다