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Status:

COMPLETED

Epothilone B in Treating Patients With CNS Metastases From Breast Cancer

Lead Sponsor:

David Peereboom, MD

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Metastatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as epothilone B, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This pha...

Detailed Description

OBJECTIVES: Primary * Determine the 3-month CNS-progression free survival of patients with CNS metastases secondary to breast cancer treated with epothilone B. Secondary * Determine the toxicity o...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed carcinoma of the breast
  • CNS metastases (i.e., brain parenchymal lesions and/or leptomeningeal disease), meeting 1 of the following criteria:
  • Recurrent or progressive CNS metastases after whole brain radiotherapy
  • If only evaluable site of CNS progression has been previously treated with stereotactic radiosurgery, radiation necrosis must be excluded by radiographic (e.g., positron emission tomography scan or magnetic resonance spectroscopy) or histologic assessment
  • Newly diagnosed, untreated, asymptomatic brain or leptomeningeal metastases
  • Patient must be neurologically stable, as demonstrated by a stable dose of steroids and anticonvulsants for ≥ 1 week prior to obtaining baseline gadolinium-enhanced MRI of the brain and/or ≥ 1 week prior to beginning study treatment
  • No CNS complications requiring urgent neurosurgical intervention (e.g., resection or shunt placement)
  • Hormone receptor status not specified
  • PATIENT CHARACTERISTICS:
  • Male or female
  • Menopausal status not specified
  • Karnofsky performance status 60-100%
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count \> 1,500/mm\^3
  • Hemoglobin \> 9.0 g/dL
  • Platelet count \> 100,000/mm\^3 (red blood cell transfusion and repeat evaluation allowed)
  • Bilirubin \< 1.5 times upper limit of normal (ULN)
  • AST and ALT \< 2.5 times ULN
  • Alkaline phosphatase \< 2.5 times ULN
  • Creatinine \< 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study therapy
  • No known hypersensitivity to epothilones
  • No peripheral neuropathy \> grade 1
  • No unresolved diarrhea within the past 7 days
  • Grade 0 diarrhea required at study entry
  • No concurrent serious medical illness (e.g., HIV positivity or active hepatitis B or C)
  • No severe cardiac insufficiency (e.g., New York Heart Association class III-IV heart disease) with uncontrolled and/or unstable cardiac or coronary artery disease
  • No active or suspected acute or chronic uncontrolled infection, including abscess or fistulae
  • No other malignancy within the past 3 years except curatively treated nonmelanoma skin cancer, prostate cancer, or carcinoma in situ of the cervix
  • No history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits
  • No contraindications to MRI, including any of the following:
  • Pacemaker
  • Ferromagnetic implants
  • Claustrophobia
  • Extreme obesity
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • More than 2 weeks since prior noncytotoxic drugs (e.g., small molecule-targeted drugs) and recovered
  • More than 3 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
  • More than 3 weeks since prior intracranial surgery and recovered
  • More than 4 weeks since prior radiotherapy and recovered
  • More than 4 weeks since prior major surgery
  • More than 28 days since prior investigational compounds or drugs
  • No prior epothilones
  • No concurrent known diarrheagenic agents
  • No other concurrent anticancer agents, including investigational agents, biological agents, or chemotherapy
  • No other concurrent experimental therapies
  • Concurrent hormone therapy and/or trastuzumab (Herceptin®) allowed
  • No concurrent Coumadin® or other agents containing warfarin
  • Low dose Coumadin® (≤ 1 mg) for prophylactic maintenance of indwelling lines or ports allowed
  • No concurrent radiotherapy for central metastases (e.g., vertebral or mediastinal metastases)
  • Concurrent radiotherapy for local peripheral metastases not being used as marker lesions allowed
  • No concurrent prophylactic hematopoietic growth factors during course 1
  • No concurrent herbal or nontraditional medications

Exclusion

    Key Trial Info

    Start Date :

    January 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2012

    Estimated Enrollment :

    55 Patients enrolled

    Trial Details

    Trial ID

    NCT00450866

    Start Date

    January 1 2007

    End Date

    May 1 2012

    Last Update

    February 28 2014

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Massachusetts General Hospital

    Boston, Massachusetts, United States, 02114

    2

    University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, United States, 48109

    3

    Memorial Sloan-Kettering Cancer Center

    New York, New York, United States, 10065

    4

    Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, United States, 44106-5065