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Breast CancerPhase 2NCT00450866

Epothilone B in Treating Patients With CNS Metastases From Breast Cancer

A Phase 2 study testing epothilone B in people with Breast Cancer and Metastatic Cancer, run by David Peereboom, MD at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Metastatic Cancer
What is being tested?
epothilone B
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
5 sitesUnited States
Study dates
Jan 2007to May 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites
  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

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

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

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

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.

Read the 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 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.

Being tested
epothilone B
Keywords
recurrent breast cancer, stage IV breast cancer, tumors metastatic to brain, leptomeningeal metastases, male breast cancer
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis, Brain Neoplasms, Meningeal Carcinomatosis, Breast Neoplasms, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • epothilone BBiological

    Also called Patupilone

    Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.

Study groups in NCT00450866
Study groupRoleWhat they receive
Epothilone BExperimentalNot described
Receives: Biological: epothilone B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Central Nervous System (CNS) Progression-free Survival(PFS)

    The number of patients that are documented to have progression free survival at 3 months after treatment. Progression free is define as <25% increase in tumor area.

    PFS will be measured from the date of entry into the trial to the date of documented progression of brain metastases or death.

    Measured: 3 months after treatment

Secondary outcomes (4)
  1. Toxicity as Measured by NCI CTCAE v3.0

    Percent of patients that experience the most common grade 3 and above toxicities possibly related to study drug - to be measured using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.

    Measured: 3 months after treatment

  2. CNS Response Rate, for Measurable Disease Will be Assessed by the Modified McDonald Criteria

    Complete Response (CR): the circumstance when the tumor is no longer seen by neuroimaging Partial Response (PR): Decrease of >50% in the product of two diameters Stable Disease (SD): the circumstance when the scan shows no change. Progression (P): a > 25% increase in tumor area (two diameters)

    Measured: 3 months after treatment

  3. Systemic Disease Response Rate for Measurable Disease Will be Assessed by the Modified McDonald Criteria

    Complete Response (CR): the circumstance when the tumor is no longer seen by neuroimaging Partial Response (PR): Decrease of >50% in the product of two diameters Stable Disease (SD): the circumstance when the scan shows no change. Progression (P): a > 25% increase in tumor area (two diameters)

    Measured: 3 months after treatment

  4. Overall Survival

    Median time (months) that patients survived during the duration of the study.

    Measured: 48 months from start of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionJun 2011
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00450866
Sponsor's protocol ID
CASE5106
Other IDs
P30CA043703, MSKCC-07036
Status last verified
Jan 2014
First submitted
20 Mar 2007
Last updated
28 Feb 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing epothilone B in people with Breast Cancer and Metastatic Cancer, run by David Peereboom, MD at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central Nervous System (CNS) Progression-free Survival(PFS) (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014.

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