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.
OBJECTIVES: Primary * Determine the objective response rate in patients with stage IV breast cancer treated with gemcitabine hydrochloride and genistein. Secondary * 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
Gemcitabine IV-1000mg/m2: Days 1 \& 8 every 21 days
Biopsy of tumor prior to dose of genistein (Novasoy)
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Objective Response Rate by RECIST Criteria Following
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: every 2 courses until disease progression or death, up to 24 weeks
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