Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

The purpose of this study was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer.

Key facts

Study ID

NCT00593827

Run by

R-Pharm

People needed

176

Starts

2008-05-01

Expected to finish

2010-08-01

Last updated by the study team

2016-03-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) ≥ 50
• 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

You may not qualify if…

• Had prior treatment with ixabepilone or other epothilones
• 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

Where it is running

• 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
• Birmingham Hematology & Oncology Associates Llc — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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