Phase 2
N=55
Epothilone B in Treating Patients With CNS Metastases From Breast Cancer
Breast Cancer · Metastatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00450866 ↗Enrolled (actual)
55
Serious AEs
32.7%
Results posted
Oct 2013
Primary outcome: Primary: Central Nervous System (CNS) Progression-free Survival(PFS) — 12; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- epothilone B (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- David Peereboom, MD
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Central Nervous System (CNS) Progression-free Survival(PFS) |
12; 2 | — |
| SECONDARY Toxicity as Measured by NCI CTCAE v3.0 |
44 | — |
| SECONDARY CNS Response Rate, for Measurable Disease Will be Assessed by the Modified McDonald Criteria |
0; 0; 5; 0; 9; 2 | — |
| SECONDARY Systemic Disease Response Rate for Measurable Disease Will be Assessed by the Modified McDonald Criteria |
1; 7; 18; 29 | — |
| SECONDARY Overall Survival |
12.7 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00450866). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.