Breast Cancer Clinical Trial
Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and genistein, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine hydrochloride together with genistein may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine hydrochloride together with genistein works in treating women with stage IV breast cancer.
Determine the objective response rate in patients with stage IV breast cancer treated with gemcitabine hydrochloride and genistein.
Determine the duration of response and survival of patients treated with this regimen.
Determine the time to disease progression in patients treated with this regimen.
Determine the quantitative and qualitative toxic effects of this regimen in these patients.
Correlate plasma genistein levels with response in patients treated with this regimen.
OUTLINE: Patients receive oral genistein once daily on days -7 to 1. Patients also receive gemcitabine hydrochloride IV on days 1 and 8 and oral genistein once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Histologically or cytologically confirmed breast cancer
Stage IV disease
Clinical and/or radiological evidence of metastatic disease
Prior radiotherapy allowed provided there is â‰¥ 1 measurable disease site outside the radiation field
No active CNS metastases
Previously treated CNS metastases allowed provided disease is stable for â‰¥ 3 months without steroids or antiseizure medications
Hormone receptor status:
Absolute neutrophil count â‰¥ 1,500/mm^3
Platelet count â‰¥ 100,000/mm^3
Hemoglobin â‰¥ 10 g/dL
Bilirubin â‰¤3.0 mg/dL
AST and ALT â‰¤ 2.5 times upper limit of normal
Creatinine â‰¤ 1.5 mg/dL
Not pregnant or nursing
Fertile patients must use effective contraception
No serious systemic disorder that would preclude study compliance
No history of another malignancy except curatively treated carcinoma of the cervix or basal cell or squamous cell skin cancer in complete remission
No unresolved bacterial infection requiring antibiotic treatment
No known HIV-1 positivity
PRIOR CONCURRENT THERAPY:
At least 3 weeks since prior biologic therapy
Prior adjuvant chemotherapy allowed
Prior adjuvant or neoadjuvant taxane-based therapy or taxane therapy for metastatic disease allowed
Patient must have failed therapy within 2 years after completion of treatment
At least 3 weeks since prior chemotherapy
No more than 2 prior cytotoxic chemotherapy regimens for metastatic disease
No prior gemcitabine hydrochloride
No other concurrent chemotherapy
See Disease Characteristics
At least 2 weeks since prior and no concurrent hormonal therapy
Must have documented disease progression during prior hormonal therapy
See Disease Characteristics
At least 4 weeks since prior radiotherapy and recovered
No concurrent radiotherapy
At least 3 weeks since prior surgery
At least 3 weeks since prior investigational therapy
At least 1 week since prior soy supplements (e.g., soy-based pills, liquids, or concentrates)
Dietary soy as part of a meal (e.g., tofu) allowed once a week
No concurrent nutritional supplements, herbal agents, or high doses of antioxidants (e.g., vitamins C, D, or E) that may interact with, antagonize, alter, or imitate the potential effects of gemcitabine hydrochloride or genistein
A single daily multivitamin is allowed
No other concurrent immunotherapy
No other concurrent experimental medication
Concurrent anticoagulants, appetite stimulants, and replacement steroids allowed
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There is 1 Location for this study
Detroit Michigan, 48201, United States
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