Epothilone B in Treating Patients With CNS Metastases From Breast Cancer (NCT00450866) | Clinical Trial Compass
CompletedPhase 2
Epothilone B in Treating Patients With CNS Metastases From Breast Cancer
United States55 participantsStarted 2007-01
Plain-language 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 phase II trial is studying how well epothilone B works in treating patients with CNS metastases from breast cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* …
What they're measuring
1
Central Nervous System (CNS) Progression-free Survival(PFS)