Clinical Drug Experience Knowledgebase

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed adenocarcinoma of the breast
Locally recurrent disease that is not amenable to surgical resection with curative intent OR
Metastatic disease

No HER-2-overexpressing (3+) breast cancer unless previously treated with trastuzumab (Herceptin)

Unknown HER-2 status allowed provided herceptin-based therapy inappropriate or not indicated
No prior or radiologic evidence of CNS metastases, including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement by head CT scan or MRI

Hormone receptor status:

Not specified

PATIENT CHARACTERISTICS:

Age:

18 and over

Sex:

Male or female

Menopausal status:

Not specified

Performance status:

ECOG 0-1

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
No prior bleeding diathesis

Hepatic:

Bilirubin no greater than 1.5 mg/dL
SGOT no greater than 2 times upper limit of normal (ULN) (5 times ULN for known liver involvement)
PT/PTT no greater than 1.5 times normal
INR no greater than 1.5 times normal

Renal:

Creatinine no greater than 2.0 mg/dL
No proteinuria by dipstick urinalysis
Trace proteinuria allowed
Proteinuria less than 500 mg by 24-hour urine collection if proteinuria at least 1+ by urinalysis

Cardiovascular:

No clinically significant cardiovascular disease
No myocardial infarction within the past 12 months
No unstable angina
No prior deep vein thrombosis
No grade 2 or greater peripheral vascular disease
No uncontrolled congestive heart failure
No uncontrolled hypertension (systolic blood pressure greater than 170 mmHg and diastolic blood pressure greater than 95 mm Hg)
No prior cerebrovascular accident

Pulmonary:

No prior pulmonary embolism

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective non-hormonal contraception
No history of seizures
No non-healing wound or fracture
No hypersensitivity to paclitaxel, Cremophor EL, Chinese hamster ovary cell products, or other recombinant human antibodies
No active infection requiring parenteral antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Disease Characteristics

Chemotherapy:

No prior chemotherapy for locally recurrent or metastatic breast cancer
At least 12 months since prior adjuvant or neoadjuvant taxane therapy
At least 3 weeks since prior adjuvant chemotherapy

Endocrine therapy:

At least 3 weeks since prior hormonal therapy for locally recurrent or metastatic breast cancer

Radiotherapy:

At least 3 weeks since prior radiotherapy
No prior radiotherapy to only site of disease
No concurrent local radiotherapy for pain control or life-threatening situations (e.g, superior vena cava syndrome, spinal cord compression, or CNS metastases)

Surgery:

At least 4 weeks since prior major surgical procedure except placement of vascular access device or breast biopsy
At least 7 days since prior minor surgical procedure, including placement of an access device or fine needle aspiration

Other:

At least 10 days since prior anticoagulant therapy (low-dose anticoagulant therapy to maintain patency of a vascular access device allowed)
At least 10 days since prior and no concurrent daily aspirin (more than 325 mg/day) or other non-steroidal anti-inflammatory medication known to inhibit platelet function
No concurrent dipyridamole, ticlopidine, clopidogrel, or cilostazol