3-AP and Gemcitabine in Treating Patients With Refractory Metastatic Breast Cancer

Inclusion Criteria:

Histologically or cytologically confirmed breast cancer

Refractory metastatic disease

Measurable disease

At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Must have received 1, and only 1, prior chemotherapy regimen for metastatic disease
Patients overexpressing HER2/neu antigen must have received a prior trastuzumab (Herceptin®)-containing regimen
No known brain metastases

Hormone receptor status:

Not specified
Male or female
Performance status - ECOG 0-2
At least 12 weeks
WBC ≥ 3,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin normal
AST and ALT ≤ 2.5 times upper limit of normal
Creatinine normal
Creatinine clearance ≥ 60 mL/min
No uncontrolled congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
No severe pulmonary disease requiring oxygen
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No glucose-6-phosphate dehydrogenase (G6PD) deficiency
No other uncontrolled illness
No active or ongoing infection
No history of allergic reaction attributed to compounds of similar chemical or biological composition to 3-AP (Triapine®) or other study agents
No psychiatric illness or social situation that would preclude study compliance
No other malignancy within the past 5 years
See Disease Characteristics
No concurrent immunotherapy
No concurrent routine colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
See Disease Characteristics
More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
No prior gemcitabine for metastatic disease
No other concurrent chemotherapy
More than 4 weeks since prior hormonal therapy
More than 4 weeks since prior radiotherapy
No concurrent radiotherapy
Recovered from prior therapy
No concurrent antiretroviral therapy for HIV-positive patients
No other concurrent investigational therapy