Capecitabine in Treating Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: capecitabine
Intervention description: A total of 115 cycles of therapy were administered and five patients did not complete cycle 1. The median number of cycles initiated was four (range 1-16).
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IV breast cancer; male breast cancer; recurrent breast cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying how well capecitabine works in treating patients
      with metastatic breast cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast

               -  Evidence of metastatic involvement (stage IV disease)

          -  Patients must have measurable disease

               -  At least one measurable lesion as defined by the Response Evaluation Criteria in
                  Solid Tumors (RECIST)

          -  Treated brain metastases (surgery or radiation therapy) allowed if clinically stable

          -  Patients with leptomeningeal disease are ineligible

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Male or female

          -  Menopausal status not specified

          -  Absolute neutrophil count (ANC) ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Creatinine clearance > 50 mL/min

          -  Fertile patients must use effective contraception

          -  No history of another severe and/or life-threatening medical disease

          -  No other active primary malignancy

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Patients with asymptomatic HIV infection are eligible

          -  Liver dysfunction score ≤ 9

          -  No pre-existing liver disease (i.e., cirrhosis or active viral hepatitis)

          -  No active gastrointestinal malabsorption illness

          -  No clinically significant cardiac disease, including the following:

               -  Congestive heart failure, symptomatic coronary artery disease, and cardiac
                  arrhythmias not well controlled with medication, or myocardial infarction within
                  the past six months

          -  No prior unanticipated severe reaction to fluoropyrimidine therapy, known
             hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency

          -  No history of uncontrolled seizures or central nervous system disorders

          -  No significant history of noncompliance to medical regimens

          -  No clinically significant psychiatric disability that would preclude study compliance

        PRIOR CONCURRENT THERAPY:

          -  No previous capecitabine

          -  Up to 3 prior cytotoxic regimens allowed for metastatic disease

               -  Prior noncytotoxic therapy allowed (e.g., hormonal treatment or trastuzumab)

          -  No other concurrent therapies intended to treat the primary condition including
             chemotherapy, biologic agents, or immunotherapy

          -  No concurrent anti-estrogen therapy, radiation therapy, or investigational systemic
             therapy

          -  No other concurrent investigational drugs

          -  No concurrent use of the following drugs: warfarin for full anticoagulation,
             cimetidine, or azidothymidine (AZT)

               -  Mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed

          -  At least 4 weeks since prior sorivudine or brivudine

          -  Concurrent use of bisphosphonates allowed if initiated before beginning study therapy

          -  Concurrent use of megestrol acetate suspension as an appetite stimulant allowed