Epothilone B in Treating Patients With CNS Metastases From Breast Cancer

NCT ID: NCT00450866

Last Updated: 2014-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2012-05-31

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epothilone B

Group Type: EXPERIMENTAL

epothilone B

Intervention Type: BIOLOGICAL

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.

Interventions

epothilone B

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Patupilone

Eligibility Criteria

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

David Peereboom, MD

OTHER

Sponsor Role: lead

Responsible Party

David Peereboom, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David M. Peereboom, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Joseph Baar, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

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

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MSKCC-07036

Identifier Type: OTHER

Identifier Source: secondary_id

CASE5106

Identifier Type: -

Identifier Source: org_study_id