Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer
NCT ID: NCT00546364
Last Updated: 2016-03-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
62 participants
INTERVENTIONAL
2008-02-29
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
Ixabepilone, 32 mg/m\^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
Docetaxel 75 mg/m\^2 administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
Interventions
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Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
Ixabepilone, 32 mg/m\^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
Docetaxel 75 mg/m\^2 administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease
* Up to 1 chemotherapy regimen is acceptable. Participants who have received paclitaxel in the neoadjuvant or adjuvant setting acceptable, only if the last dose of paclitaxel was received 12 months or less before the treatment. There is no timeframe for prior paclitaxel in the metastatic setting.
* Human epidermal growth factor receptor 2-positive participants allowed if they have progressed after receiving treatment with trastuzumab or lapatinib
* Eastern Cooperative Oncology Group Performance status of 0-1
* Age younger than 18 years
* Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of investigational products
Exclusion Criteria
* Prior treatment with any epothilone, capecitabine, or docetaxel
* Prior radiation must not have included 30% or more of major bone marrow-containing areas (pelvis, lumbar spine). If prior radiation was less than 30%, a minimum interval of 2 weeks must be allowed between the last radiation treatment and administration of study medication. There must be at least 1 week between focal/palliative radiation and administration of study medication.
* Any current or previous history of brain and/or leptomeningeal metastases
* Neuropathy greater than Grade 2
* Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
* Uncontrolled diabetes mellitus
* Chronic hepatitis
* HIV-positive status
* Administration of trastuzumab, lapatinib, bevacizumab, or other systemic treatment for cancer must be discontinued 28 days prior to study medication. Hormonal anticancer agents must be discontinued at least 14 days prior to study medication. Hormonal replacement therapy is acceptable
* Biphosphonates for palliation of bone metastases allowed if initiated at least 7 days before study entry
18 Years
ALL
No
Sponsors
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R-Pharm
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Dch Cancer Treatment Center
Tuscaloosa, Alabama, United States
Scripps Cancer Center
La Jolla, California, United States
Cancer Center of Central Connecticut
Southington, Connecticut, United States
Local Institution
Newark, Delaware, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Local Institution
Jacksonville, Florida, United States
Local Institution
Miami, Florida, United States
Medical Oncology Associates of Augusta, PC
Augusta, Georgia, United States
Local Institution
Honolulu, Hawaii, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
John W Kugler, MD
Peoria, Illinois, United States
Midwestern Regional Medical Center
Zion, Illinois, United States
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States
Monroe Medical Associates
Munster, Indiana, United States
Cancer Center of Kansas
Wichita, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
University Medical Center, Inc
Louisville, Kentucky, United States
Hematology/Oncology Clinic
Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Center for Cancer & Blood Disorders, PC
Bethesda, Maryland, United States
Jackson Oncology Associates, Pllc
Jackson, Mississippi, United States
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Howell Office Plaza
Howell Township, New Jersey, United States
Local Institution
Newark, New Jersey, United States
Cooper Hospital, Division of Hematology/Oncology
Voorhees Township, New Jersey, United States
UNM Cancer Center
Albuquerque, New Mexico, United States
New Mexico Cancer Care Associates (NMCCA)
Santa Fe, New Mexico, United States
Arena Oncology Associates, PC
Lake Success, New York, United States
Hematology Oncology Associates of Rockland
Nyack, New York, United States
Gaston Hematology and Oncology
Gastonia, North Carolina, United States
Marion L Shepard Cancer Center
Washington, North Carolina, United States
Akron General Medical Center
Akron, Ohio, United States
Summa Health System
Akron, Ohio, United States
Local Institution
Canton, Ohio, United States
Mid Ohio Oncology/Hematology, Inc, dba The Mark H Zangmeister Center
Columbus, Ohio, United States
Doylestown Hospital
Doylestown, Pennsylvania, United States
Hematology & Oncology Associates of Nepa
Dunmore, Pennsylvania, United States
Regional Hematology Oncology, PC
Langhorne, Pennsylvania, United States
St Mary Medical Center
Langhorne, Pennsylvania, United States
Local Institution
Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
Local Institution
Woonsocket, Rhode Island, United States
Charleston Cancer Center
Charleston, South Carolina, United States
Lowcountry Hematology & Oncology, PA
Mt. Pleasant, South Carolina, United States
Santee Hematology/Oncology
Sumter, South Carolina, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Kingsport Hematology Oncology
Kingsport, Tennessee, United States
The University of Tennessee Medical Center
Knoxville, Tennessee, United States
Austin Cancer Centers
Austin, Texas, United States
Cancer Specialists of South Texas
Corpus Christi, Texas, United States
Coastal Bend Cancer Center
Corpus Christi, Texas, United States
Edward L Middleman, MD
Duncanville, Texas, United States
Section Chief Medical Oncology
Houston, Texas, United States
Jose A Figueroa, MD
Lubbock, Texas, United States
Southlake Oncology
Southlake, Texas, United States
Peninsula Cancer Institute
Newport News, Virginia, United States
Providence Cancer Center
Spokane, Washington, United States
Leah L Dietrich, MD
La Crosse, Wisconsin, United States
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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CA163-131
Identifier Type: -
Identifier Source: org_study_id
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