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

9 lutego 2016 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

136

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg
Lek: 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.
Inne nazwy:
  • BMS-247550
  • IXEMPRA
Eksperymentalny: Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg
Lek: 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.
Inne nazwy:
  • BMS-247550
  • IXEMPRA
Aktywny komparator: Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg
Lek: 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.
Inne nazwy:
  • TAKOL
  • BMS-181339

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants With Progression-free Survival at Week 24
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

R-Pharm

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 marca 2007

Zakończenie podstawowe (Rzeczywisty)

1 listopada 2009

Ukończenie studiów (Rzeczywisty)

1 listopada 2009

Daty rejestracji na studia

Pierwszy przesłany

30 sierpnia 2006

Pierwszy przesłany, który spełnia kryteria kontroli jakości

30 sierpnia 2006

Pierwszy wysłany (Oszacować)

31 sierpnia 2006

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

10 marca 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 lutego 2016

Ostatnia weryfikacja

1 lutego 2016

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CA163-115

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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Badania kliniczne na Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg

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