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Trial Details for Trial CA163-115

Purpose: 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 subjects with MBC. The safety of this combination treatment will also be studied.

Overall Recruitment Status: Completed

Condition(s): Metastatic Breast Cancer

Intervention(s): Bevacizumab, Ixabepilone, Paclitaxel

Phase: Phase 2

Study Type: Interventional

Study Design: Allocation: Randomized,Control: Active Control,Endpoint Classification: Efficacy Study,Intervention Model: Parallel Assignment,Masking: Open Label,Primary Purpose: Treatment

Official Title: 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

Primary Outcome Measures:

  • Response Rate
       Time Frame : 20 months after last patient first visit


    • Secondary Outcome Measures:
  • duration of response
       Time Frame : 20 months after last patient first visit
  • time to response
       Time Frame : 20 months from last patient first visit
  • week 24 PFS (progression free survival)
       Time Frame : 20 months from last patient first visit
  • PFS and OS (overall survival)
       Time Frame : 20 months after last patient first visit



    • Arms Assigned Interventions
    Ixabepilone + Bevacizumab (Arm A):Experimental
    		 Drug:Ixabepilone
      IV solution, Intravenous, 16 mg/m2, wkly x 3 q 4 wks, until PD or unacceptable toxicity
    Drug:Bevacizumab
      IV solution, IV, 10 mg/kg, q 2 wks, until PD or unacceptable toxicity
    Ixabepilone + Bevacizumab (Arm B):Experimental
    		 Drug:Ixabepilone
      IV solution, Intravenous, 40 mg/m2, every 3 wks, until PD or unacceptable toxicity
    Drug:Bevacizumab
      IV solution, IV, 15 mg/kg, every 3 wks until PD or unacceptable toxicity
    Paclitaxel + Bevacizumab (Arm C):Active Comparator
    		 Drug:Paclitaxel
      IV solution, Intravenous, 90 mg/m2, wkly x 3 every 4 wks, until PD or unacceptable toxicity
    Drug:Bevacizumab
      IV solution, IV, 10 mg/kg, q 2 wks, until PD or unacceptable toxicity


    Actual Enrollment: 123

    Study Start Date: March 2007

    Actual Primary Completion Date: November 2009

    Download Date: Information obtained from ClinicalTrials.gov on August 31, 2010

    Link Text: Link to the current ClinicalTrials.gov record.

    URL: http://clinicaltrials.gov/show/NCT00370552

    Eligibility

    Minimum age: 18 Years

    Maximum age: N/A

    Gender(s): Both

    Criteria :
    Inclusion Criteria:

    • Men or women ages > =18 years
    • Histologic or cytologic confirmed diagnosis of invasive adenocarcinoma originating in the breast
    • At least one measurable lesion. Locally recurrent disease must be not be amenable to resection with curative intent
    • Subjects must not have received cytotoxic chemotherapy for locally recurrent/metastatic disease
    • Subjects who received prior adjuvant or neoadjuvant taxane therapy must have relapsed > =12 months after completing therapy
    • Subjects must not have breast cancer known to over express or amplify Her-2
    • Prior hormonal is allowed, but this must have been discontinued at least 2 weeks prior to randomization
    • Karnofsky performance status (PS) of 80-100 (or ECOG, PS of 0-1)
    • Adequate hematologic, hepatic and renal function

    General Contact Information

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     More Information

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        Health Authority :   United States: Food and Drug Administration