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Phase II Trial of Patupilone in Patients With Brain Metastases From Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer, Metastatic Cancer

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Trial Information

Phase II Trial of Patupilone in Patients With Brain Metastases From Breast Cancer



- Determine the 3-month CNS-progression free survival of patients with CNS metastases
secondary to breast cancer treated with epothilone B.


- Determine the toxicity of this drug in these patients.

- Determine the CNS response rate and duration of CNS response in patients treated with
this drug.

- Determine the systemic disease response rate and duration of systemic response in
patients treated with this drug.

- Determine the overall survival of patients treated with this drug.

OUTLINE: This is a multicenter, open-label study.

Patients receive epothilone B IV over 20 minutes on day 1. Courses repeat every 21 days in
the absence of disease progression, satisfactory response, or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Inclusion Criteria


- 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


- 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

- 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

- 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

- 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


- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CNS progression-free survival and overall survival

Outcome Time Frame:

3 months after treatment

Safety Issue:


Principal Investigator

David M. Peereboom, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2007

Completion Date:

May 2012

Related Keywords:

  • Breast Cancer
  • Metastatic Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • tumors metastatic to brain
  • leptomeningeal metastases
  • male breast cancer
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland, Ohio  44195