A Phase II Clinical Trial Of BMS-247550 (NSC 710428), An Epothilone B Analog, In Patients With Breast Carcinoma
18 Years
N/A
Both
Breast Cancer
Trial Information
A Phase II Clinical Trial Of BMS-247550 (NSC 710428), An Epothilone B Analog, In Patients With Breast Carcinoma
OBJECTIVES:
- Determine any antitumor activity of ixabepilone, in terms of objective response rate,
in patients with incurable, locally advanced or metastatic breast cancer.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior taxane
therapy (yes vs no).
Patients (with or without prior taxane exposure) receive ixabepilone IV over 1 hour on days
1-5. An additional cohort of 37 patients who have received prior taxane therapy are then
accrued to receive ixabepilone IV over 1 hour on days 1-3 at a higher starting dose. For all
patients, courses repeat every 3 weeks in the absence of disease progression or unacceptable
toxicity. Patients who receive more than 6 courses with satisfactory response may be treated
every 4-5 weeks.
Patients removed for unacceptable toxicty are followed periodically.
PROJECTED ACCRUAL: A total of 105 patients (at least 74 with and 21 without prior taxane
exposure) will be accrued for this study within 26 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed* adenocarcinoma of the breast
- Incurable, locally advanced or metastatic disease
- Primarily stage IV disease, but some inoperable stage III disease may be
eligible (e.g., a patient with T4 and/or N2-3 disease who cannot receive
doxorubicin or who has already received other therapy) NOTE: *Patients with no
available tissue for histologic confirmation but who have documentation of
breast surgery and prior chemotherapy are eligible upon approval of the
principal investigator
- Measurable disease
- No evidence of CNS metastases by brain MRI or contrast head CT scan
- CNS metastases controlled by radiotherapy or surgical resection at least 6
months prior to study enrollment are allowed
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female or male
Menopausal status
- Not specified
Performance status
- ECOG 0-2
Life expectancy
- At least 3 months
Hematopoietic
- Granulocyte count at least 1,200/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN) (3 times ULN if there
is clinical evidence of Gilbert's disease)
- AST and ALT no greater than 2.5 times ULN
Renal
- Creatinine normal OR
- Creatinine clearance greater than 40 mL/min
Other
- No poor medical risk due to other nonmalignant systemic disease
- No active uncontrolled infection
- No sensory, motor, or cranial neuropathy or neuropathic pain grade 2 or greater
(unless neuropathy is clearly due to underlying breast cancer)
- No other concurrent serious medical illness
- No prior severe hypersensitivity reactions to agents containing Cremophor EL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study
participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior filgrastim (G-CSF), pegfilgrastim, or thrombopoietin
(or other platelet growth factors)
- No concurrent immunotherapy
Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No other concurrent chemotherapy for breast cancer
Endocrine therapy
- More than 2 weeks since prior hormonal therapy
- No concurrent hormonal therapy
Radiotherapy
- See Disease Characteristics
- No prior craniospinal radiation
- No prior total body irradiation
- More than 4 weeks since prior radiotherapy
Surgery
- See Disease Characteristics
Other
- No other concurrent investigational drugs
- No concurrent cytochrome p450 3A4 inhibitors, including any of the following:
- Clarithromycin
- Erythromycin
- Troleandomycin
- Delaviridine
- Nelfinavir
- Amprenavir
- Ritonavir
- Indinavir
- Saquinavir
- Lopinavir
- Itraconazole
- Ketoconazole
- Fluconazole (> 200 mg/day)
- Voriconazole
- Nefazodone
- Fluvoxamine
- Verapamil
- Diltiazem
- Amiodarone
- Concurrent bisphosphonates for bone metastases allowed
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Anti-tumor activity as measured by CT scans and bone scans at baseline and every other course
Safety Issue:
No
Principal Investigator
Sandra M. Swain, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
CDR0000256355
NCT ID:
NCT00045097
Start Date:
May 2002
Completion Date:
July 2007
Related Keywords:
- Breast Cancer
- male breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Suburban Hospital | Bethesda, Maryland 20814 |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
| NCI - Center for Cancer Research | Bethesda, Maryland 20892 |
| Oncology Care Associates | Bethesda, Maryland 20817 |
