Phase II Study of Ixabepilone in Patients With Metastatic Breast Cancer and a Prospective Evaluation of Its Effects on the Ultrastructure of Neurons
- Ability to understand and the willingness to sign a written informed consent
- Histologic or cytologic diagnosis of adenocarcinoma originating in the breast.
- Evidence that the cancer is metastatic or locally advanced and not curable by local
measures (i.e., surgery, radiation).
NOTE: There is no limit on number of prior chemotherapy regimens received.
- Karnofsky performance status (KPS) score of 70 - 100; (Appendix 1).
- Life expectancy of at least 12 weeks.
- Adequate recovery of drug related toxicities from prior systemic therapy (recovery to
< = Grade 1 except for Grade 2 fatigue and alopecia).
- Adequate recovery from recent surgery and radiation therapy. At least one week must
have elapsed from the time of a minor surgery and/or focal/palliative radiation
therapy; at least 3 weeks for major surgery and other radiation therapy.
- Women or Men, age > = 18 years.
- Patients must have normal organ and marrow function as defined below:
- Hematologic function with absolute neutrophils ≥ 1,500/mm3 and/or platelets >
- Hepatic function with serum bilirubin less than 1.5 times the upper
institutional limits of normal, ALT ≤ 2.5 times the upper institutional limits
of normal (≤ 5 times the upper institutional limits of normal if documented
hepatic metastases are present)
- Renal function with serum creatinine ≤ 1.5 times the upper limit of normal
- Women of childbearing potential (WOCBP) and men with partners who are of childbearing
potential must be using an adequate method of contraception to avoid pregnancy
throughout the study and for up to 4 weeks after the study in such a manner that the
risk of pregnancy is minimized.
WOCBP include any female who has experienced menarche and who has not undergone successful
surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy)
or is not postmenopausal (defined as amenorrhea > = 12 consecutive months; or women on
hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH)
level > 35 mIU/mL). Even women who are using oral, implanted or injectable contraceptive
hormones or mechanical products such as an intrauterine device or barrier methods
(diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where
partner is sterile (e.g., vasectomy), should be considered to be of child bearing
- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or
equivalent units of HCG) within 72 hours prior to the start of study medication.
Should a woman become pregnant or suspect she is pregnant while participating in this
study, she should inform her treating physician immediately.
- Patients with known and active brain and/or leptomeningeal metastases should be
excluded from this clinical trial because of their poor prognosis and because they
often develop progressive neurologic dysfunction that would confound the evaluation
of neurologic and other adverse events.
- CTC Grade 2 or greater neuropathy (motor or sensory) at study entry.
- Prior treatment with ixabepilone.
- Serious intercurrent infections, or nonmalignant medical illnesses that are
uncontrolled or whose control may be jeopardized by the complications of this
therapy, including, but not limited to: ongoing or active infection, symptomatic
congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or
psychiatric illness/social situations that would limit compliance with study
- Known history of HIV infection.
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients may not be receiving any other concurrent chemotherapy, hormonal therapy,
immunotherapy regimens or radiation therapy, standard or investigational.
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to ixabepilone.
- Known prior severe hypersensitivity reactions to agents containing CremophorEL.
- Patients may not be receiving any prohibited therapies and/or medications.
- Pregnant and lactating women are excluded from the study because the risks to an
unborn fetus or potential risks in nursing infants are unknown.