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.
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
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.
- Conditions
- Breast Cancer, Metastatic Cancer
- 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 group | Role | What they receive |
|---|---|---|
| Epothilone B | Experimental | Not described Receives: Biological: epothilone B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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.
- First posted22 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionJun 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- David Peereboom, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, David Peereboom, MD, Case Comprehensive Cancer Center
- Investigators
- David M. Peereboom, MD, Principal investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterJoseph Baar, MD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Patupilone in Patients With Brain Metastases From Breast Cancer
- ClinicalTrials.gov ID
- NCT00450866
- Acronym / sponsor ID
- CASE5106
- Conditions
- Breast Cancer, Metastatic Cancer
- Keywords
- recurrent breast cancer, stage IV breast cancer, tumors metastatic to brain, leptomeningeal metastases, male breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- David Peereboom, MDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 22 Mar 2007 (estimated)
- Results
- Posted 9 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epothilone B | Experimental | Biological: epothilone B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epothilone BAlso: PatupilonePatupilone 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. | Biological | Epothilone B |
Primary outcome
Central Nervous System (CNS) Progression-free Survival(PFS)
Time frame: 3 months after treatment
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.
4 secondary outcomes
Toxicity as Measured by NCI CTCAE v3.0
Time frame: 3 months after treatment
CNS Response Rate, for Measurable Disease Will be Assessed by the Modified McDonald Criteria
Time frame: 3 months after treatment
Systemic Disease Response Rate for Measurable Disease Will be Assessed by the Modified McDonald Criteria
Time frame: 3 months after treatment
Overall Survival
Time frame: 48 months from start of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M. Peereboom, MD principal investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Joseph Baar, MD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
5 sites in 1 country: see every site and its status.
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.