NCT00049244

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining BMS-247550 with capecitabine in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy with a taxane and an anthracycline.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2002

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

First QC Date

November 12, 2002

Last Update Submit

January 27, 2017

Conditions

Breast Cancer

Keywords

recurrent breast cancerstage IV breast cancer

Interventions

capecitabineDRUG
ixabepiloneDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed breast cancer * Metastatic disease by radiography or histology * Must have received prior chemotherapy with a taxane and an anthracycline in the adjuvant or metastatic setting * No more than 2 prior chemotherapy regimens in the metastatic setting * Measurable or evaluable disease * Bone lesions not measurable * Primary breast lesions not measurable if assessed only by physical exam * No active brain metastasis * No cerebral edema by CT scan or MRI * No progression since prior imaging studies * No requirement for steroids * No clinical symptoms of brain metastasis * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Not specified Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * ALT no greater than 2.5 times ULN Renal * Creatinine less than 1.5 times ULN Cardiovascular * No uncontrolled or significant cardiovascular disease * No myocardial infarction within the past year * No uncontrolled angina within the past year * No history of congestive heart failure * No history of atrial or ventricular arrhythmias * No history of second- or third-degree heart block * No uncontrolled hypertension Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No hypersensitivity to Cremophor EL or fluorouracil * No prior intolerance to fluoropyrimidines * No other serious uncontrolled medical disorder or active infection that would preclude study * No dementia or altered mental status that would preclude study * No grade 2 or greater neuropathy (neuromotor or neurosensory) PRIOR CONCURRENT THERAPY: Biologic therapy * See Chemotherapy * Prior immunotherapy allowed * No concurrent trastuzumab (Herceptin) * No concurrent immunotherapy Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or doxorubicin HCl liposome) * At least 2 years since prior high-dose chemotherapy with bone marrow transplantation or peripheral blood stem cell support * No prior epothilone, capecitabine, or continuous-infusion fluorouracil * No other concurrent chemotherapy Endocrine therapy * Prior hormonal therapy allowed * No concurrent hormonal therapy * Concurrent hormone replacement therapy allowed Radiotherapy * At least 3 weeks since prior radiotherapy * No prior radiotherapy to more than 25% of the bone marrow * No concurrent therapeutic radiotherapy Surgery * Not specified Other * At least 3 weeks since prior investigational cytotoxic agents * No concurrent warfarin for therapeutic anticoagulation * Low-dose warfarin allowed for implanted ports or indwelling catheters * No other concurrent experimental anticancer medications * No other concurrent antitumor therapy * Concurrent bisphosphonates for palliation of bone metastases allowed if initiated before study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabineixabepilone

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Linnea Chap, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 12, 2002

First Posted

January 27, 2003

Study Start

September 1, 2002

Last Updated

January 30, 2017

Record last verified: 2017-01

Locations

US(1)