Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: genistein; gemcitabine; Tumor biopsy
Intervention description: 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)
Intervention MeSH terms: Gemcitabine; Genistein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IV breast cancer; recurrent breast cancer

Summary:

      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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed breast cancer

               -  Stage IV disease

               -  Clinical and/or radiological evidence of metastatic disease

          -  Measurable disease

               -  Prior radiotherapy allowed provided there is ≥ 1 measurable disease site outside
                  the radiation field

          -  No active CNS metastases

               -  Previously treated CNS metastases allowed provided disease is stable for ≥ 3
                  months without steroids or antiseizure medications

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Sex

          -  Female

        Menopausal status

          -  Not specified

        Performance status

          -  SWOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 10 g/dL

        Hepatic

          -  Bilirubin ≤3.0 mg/dL

          -  AST and ALT ≤ 2.5 times upper limit of normal

        Renal

          -  Creatinine ≤ 1.5 mg/dL

        Other

          -  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:

        Biologic therapy

          -  At least 3 weeks since prior biologic therapy

        Chemotherapy

          -  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

        Endocrine therapy

          -  See Disease Characteristics

          -  At least 2 weeks since prior and no concurrent hormonal therapy

               -  Must have documented disease progression during prior hormonal therapy

        Radiotherapy

          -  See Disease Characteristics

          -  At least 4 weeks since prior radiotherapy and recovered

          -  No concurrent radiotherapy

        Surgery

          -  At least 3 weeks since prior surgery

        Other

          -  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