3-AP and Gemcitabine in Treating Patients With Refractory Metastatic Breast Cancer
Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
About this trial
This is an interventional treatment trial for Male Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Experimental
Treatment (triapine, gemcitabine hydrochloride)
Patients receive 3-AP (Triapine®) IV over 2 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.