S0430 Cyclophosphamide and Capecitabine in Treating Women With Stage IV Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: capecitabine; cyclophosphamide
Intervention MeSH terms: Cyclophosphamide; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IV breast cancer; recurrent breast cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and capecitabine, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Giving more than one chemotherapy drug may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with
      capecitabine works in treating women with stage IV breast cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed stage IV breast cancer

               -  Metastatic disease (M1) OR multiple sites of new disease that is clinically
                  obvious metastatic disease (i.e., multiple sites of new osseous disease)

          -  Meets 1 of the following criteria:

               -  Measurable disease

               -  Non-measurable disease

                    -  MUC-1 antigen level > 2 times upper limit of normal AND level has increased
                       by 1.5 times

          -  Must have documented MUC-1 antigen level

               -  Either cancer antigen (CA) 15-3 or CA 27-29 allowed

          -  Must have received at least 1 prior hormonal therapy for metastatic disease (estogen
             receptor-positive patients only)

          -  No symptomatic brain or CNS metastases

               -  Previously treated brain or CNS metastasis allowed provided radiotherapy was
                  completed ≥ 8 weeks before study entry

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Sex

          -  Female

        Menopausal status

          -  Not specified

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  No known existing uncontrolled coagulopathy

        Hepatic

          -  Not specified

        Renal

          -  Creatinine clearance > 40 mL/min

        Cardiovascular

          -  No congestive heart failure

          -  No symptomatic coronary artery disease

          -  No cardiac arrhythmia not well controlled with medication

          -  No myocardial infarction within the past 12 months

          -  No other clinically significant cardiac disease

        Gastrointestinal

          -  Able to take oral medication

          -  No uncontrolled nausea, vomiting, or diarrhea

          -  No lack of physical integrity of the upper gastrointestinal tract

          -  No malabsorption syndrome

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No active infection requiring systemic therapy

          -  No prior severe reaction to fluoropyrimidines

          -  No known sensitivity to fluorouracil

          -  No known dihydropyrimidine dehydrogenase deficiency

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent immunotherapy or biologic therapy for breast cancer

          -  No concurrent gene therapy for breast cancer

          -  No concurrent filgrastim (G-CSF)

        Chemotherapy

          -  At least 14 days since prior chemotherapy and recovered

          -  No more than 2 prior chemotherapy regimens for metastatic disease

          -  No prior capecitabine for metastatic disease

          -  No prior oral cyclophosphamide for metastatic disease

               -  Prior IV cyclophosphamide allowed

          -  No other concurrent chemotherapy for breast cancer

        Endocrine therapy

          -  See Disease Characteristics

          -  No concurrent hormonal therapy for breast cancer

        Radiotherapy

          -  See Disease Characteristics

          -  At least 14 days since prior radiotherapy to non-CNS disease sites and recovered

          -  No concurrent radiotherapy for breast cancer

        Surgery

          -  Not specified

        Other

          -  Concurrent bisphosphonates allowed

          -  No concurrent full-dose warfarin

               -  Concurrent prophylactic warfarin (≤ 1 mg/day) to maintain port patency allowed

          -  No other concurrent antineoplastic therapy for breast cancer