Clinical Drug Experience Knowledgebase

Criteria

DISEASE CHARACTERISTICS:

Histologically proven metastatic or locally advanced, inoperable adenocarcinoma of the breast

Clinically evident metastases (e.g., clearly malignant lesions on chest x-ray or CT or abdominal CT do not require histologic confirmation)
Hot spots on bone scan not shown to be malignant on plain x-rays are not adequate evidence of malignant disease in the absence of other lesions

Must meet 1 of the following conditions:

Disease progression after 1 prior chemotherapy regimen for locally advanced or metastatic disease (which may or may not have followed a separate adjuvant regimen using chemotherapy or hormonal therapy)
Locally advanced or metastatic disease during or after 1 adjuvant or neoadjuvant chemotherapy regimen
One of the above chemotherapy regimens must have contained an anthracycline (e.g., doxorubicin, but not mitoxantrone)
Single drug substitution (e.g., methotrexate for doxorubicin) during prior combination chemotherapy allowed
Bidimensionally measurable
No clinical or radiographic evidence of brain or leptomeningeal disease

Hormone receptor status:

Not specified

PATIENT CHARACTERISTICS:

Age:

18 and over

Sex:

Female

Menopausal status:

Not specified

Performance status:

Karnofsky 60-100% OR
ECOG 0-2

Life expectancy:

At least 12 weeks

Hematopoietic:

Absolute neutrophil count at least 2,000/mm3
Platelet count at least 100,000/mm3

Hepatic:

Bilirubin normal
SGOT no greater than 2.5 times upper limit of normal

Renal:

Creatinine no greater than 2.0 mg/dL
No uncontrolled hypercalcemia

Cardiovascular:

No myocardial infarction within the past 6 months
No history of arrhythmia requiring treatment
No heart block
No clinical evidence of congestive heart failure
No unstable angina (e.g., new onset, crescendo, or rest angina)
Stable exertional angina allowed

Other:

No current symptomatic grade 2 or greater peripheral neuropathy
No history of hypersensitivity to products containing Cremophor EL (e.g., cyclosporine or teniposide) or Polysorbate 80 (e.g., IV etoposide)
No serious infection
No significant psychiatric disease that would preclude study
No other malignancy within the past 5 years except nonmelanomatous skin cancer or completely excised carcinoma in situ of the cervix
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior bone marrow or stem cell transplantation

Chemotherapy:

See Disease Characteristics
At least 3 weeks since prior chemotherapy (2 weeks for oral cyclophosphamide or 6 weeks for nitrosoureas or mitomycin)
No prior high-dose chemotherapy given with ablative intent
No prior taxoids
No other concurrent antineoplastic therapy

Endocrine therapy:

See Disease Characteristics
Prior hormonal therapy as adjuvant therapy or for metastatic disease allowed
At least 1 week since prior hormonal therapy

No concurrent corticosteroids except:

Prophylaxis or treatment for acute hypersensitivity reactions
Chronic therapy (more than 6 months) at low doses (20 mg/day or less of methylprednisolone or equivalent)

Radiotherapy:

At least 4 weeks since prior radiotherapy to major bone marrow areas
No prior high-dose radiotherapy given with ablative intent
No concurrent radiotherapy except limited palliative radiotherapy (e.g., for a solitary rib fracture) during objective response

Surgery:

See Disease Characteristics
More than 2 weeks since prior surgery except simple biopsy or placement of venous access device

Other:

At least 4 weeks since prior investigational drugs
Concurrent medications known to alter cardiac conduction (e.g., digoxin, beta blockers, or calcium channel blockers) allowed
No concurrent ketoconazole
No concurrent bisphosphonates unless initiated more than 3 months before randomization
No concurrent experimental drug or therapy