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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: R-Pharm
• Collaborator: US Oncology Research
• Treatments: Epothilones

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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