Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer
NCT ID: NCT00593827
Last Updated: 2016-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
176 participants
INTERVENTIONAL
2008-05-31
2010-08-31
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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Arm 1
ixabepilone 16 mg/m\^2 weekly for 3 weeks followed by 1 week rest
Ixabepilone
Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 16 mg/m\^2 was administered as a 1-hour IV continuous infusion on Days 1, 8, and 15 in a 28-day cycle until progressive disease or intolerable toxicity.
Arm 2
ixabepilone 40 mg/m\^2 every 3 weeks
Ixabepilone
Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day cycle provided the subject met the retreatment criteria.
Interventions
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Ixabepilone
Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 16 mg/m\^2 was administered as a 1-hour IV continuous infusion on Days 1, 8, and 15 in a 28-day cycle until progressive disease or intolerable toxicity.
Ixabepilone
Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day cycle provided the subject met the retreatment criteria.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer
* Prior chemotherapy is permitted with no limit on the number of prior regimens
* Two weeks or more have elapsed since last chemotherapy or radiation treatment
* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2
* Is female, ≥ 18 yrs of age
* Protocol defined appropriate laboratory values
* Negative pregnancy test within 7 calendar days prior to registration
* Has signed a patient informed consent
Exclusion Criteria
* Has HER2+ disease
* Has a known, prior, severe (National Cancer Institute Common Terminology Criteria Adverse Events \[NCI CTCAE\] Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil)
* Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy
* Is receiving concurrent investigational therapy or has received such therapy within the past 30 days
* Has peripheral neuropathy \> Grade 1
* Has evidence of central nervous system (CNS) involvement requiring radiation or steroid treatment. Participants with stable brain metastases who are off steroids at least 2 weeks are eligible
* Is pregnant or breast feeding
18 Years
FEMALE
No
Sponsors
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US Oncology Research
INDUSTRY
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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Birmingham Hematology & Oncology Associates Llc
Birmingham, Alabama, United States
Hematology Oncology Associates
Phoenix, Arizona, United States
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, United States
Arizona Oncology Associates D.B.A. Hematology Oncology
Tucson, Arizona, United States
Southwest Cancer Care
Murrieta, California, United States
Florida Cancer Institute
Hudson, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Cancer Centers Of Florida, P.A
Ocoee, Florida, United States
Cancer Care & Hematology Specialists Of Chicagoland
Niles, Illinois, United States
Central Indiana Cancer Centers
Carmel, Indiana, United States
Hope Center
Terre Haute, Indiana, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States
Alliance Hematology Oncology, Pa
Westminster, Maryland, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Kansas City Cancer Center, Llc
Kansas City, Missouri, United States
Arch Medical Services, Inc.
St Louis, Missouri, United States
Comprehensive Cancer Center Of Nevada
Henderson, Nevada, United States
Hematology-Oncology Assoc. Of Northern Nj, Pa
Morristown, New Jersey, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States
New York Oncology Hematology, P.C.
Amsterdam, New York, United States
Interlakes Oncology & Hematology, P.C.
Rochester, New York, United States
Regional Cancer Care
Durham, North Carolina, United States
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, United States
Cancer Centers Of The Carolinas
Greenville, South Carolina, United States
Texas Cancer Center
Arlington, Texas, United States
Texas Oncology-Central Austin Cancer Center
Austin, Texas, United States
Mamie Mcfaddin Ward Cancer Center Texas Oncology
Beaumont, Texas, United States
Texas Oncology
Bedord, Texas, United States
Texas Cancer Center At Medical City
Dallas, Texas, United States
Texas Oncology
Dallas, Texas, United States
Texas Oncology/Methodist Charlton Cancer Ctr
Dallas, Texas, United States
Baylor Sammons Cancer Ctr
Dallas, Texas, United States
Texas Oncology Sammons Cancer Center
Dallas, Texas, United States
Texas Cancer Center
Denton, Texas, United States
Texas Oncology
Fort Worth, Texas, United States
Texas Oncology
Garland, Texas, United States
Texas Oncology
Houston, Texas, United States
Texas Oncology - Lake Vista Cancer Center
Lewisville, Texas, United States
Longview Cancer Center
Longview, Texas, United States
South Texas Cancer Center
McAllen, Texas, United States
Texas Cancer Center Of Mesquite
Mesquite, Texas, United States
Texas Oncology, Pa
Midland, Texas, United States
Texas Oncology - Odessa
Odessa, Texas, United States
Paris Regional Cancer Center Lab
Paris, Texas, United States
Texas Cancer Center - Sherman
Sherman, Texas, United States
Texas Oncology Cancer Center - Sugar Land
Sugar Land, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Texas Oncology Cancer Care And Research Center
Waco, Texas, United States
Deke Slayton Cancer Center
Webster, Texas, United States
Oncology & Hematology Associates Of Southwest Virginia, Inc.
Salem, Virginia, United States
Puget Sound Cancer Centers
Edmonds, Washington, United States
Puget Sound Cancer Centers
Seattle, Washington, United States
Cancer Care Northwest
Spokane, Washington, United States
Evergreen Hematology And Oncology
Spokane, Washington, United States
Northwest Cancer Specialists, Pc
Vancouver, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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USOR 06-106
Identifier Type: -
Identifier Source: secondary_id
CA163-132
Identifier Type: -
Identifier Source: org_study_id
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