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Status:

COMPLETED

Capecitabine in Treating Patients With Metastatic Breast Cancer

Lead Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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 pha...

Detailed Description

OBJECTIVES: Primary * Determine the response rate in patients with metastatic breast cancer treated with a fixed-dose of capecitabine. Secondary * Determine the clinical benefit, time to treatment...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2012

    Estimated Enrollment :

    26 Patients enrolled

    Trial Details

    Trial ID

    NCT00274768

    Start Date

    April 1 2004

    End Date

    November 1 2012

    Last Update

    January 27 2020

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    DeCesaris Cancer Institute at Anne Arundel Medical Center

    Annapolis, Maryland, United States, 21401

    2

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, United States, 21231-2410

    3

    Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, United States, 02115