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Herceptin (NSC #688097) and Gemcitabine for Metastatic Pancreatic Cancers That Overexpress HER-2/NEU (NCT00003797)

National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gemcitabine and trastuzumab in treating patients who have metastatic cancer of the pancreas that overexpresses HER2/neu.
  • Biological: trastuzumab
    • Drug: gemcitabine hydrochloride
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      OBJECTIVES:

      - Determine the response rate and survival of patients with metastatic pancreatic cancer and overexpression of HER2/neu treated with gemcitabine and trastuzumab.

      - Determine the toxic effects of this regimen in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive gemcitabine IV over 30 minutes once weekly during weeks 1-7. Patients receive trastuzumab IV over 90 minutes once during week 1 and trastuzumab IV over 30-90 minutes once weekly during weeks 2-8.

      Patients with stable or responding disease receive gemcitabine IV over 30 minutes once weekly during weeks 1-3 and trastuzumab IV over 30 minutes once weekly during weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

      Patients are followed every 3 months for 1 year and then every 6 months thereafter.

      PROJECTED ACCRUAL: A maximum of 41 patients will be accrued for this study over 18-24 months.

      12 locations

      United States (12)
      • Rush-Presbyterian-St. Luke's Medical Center
        Not specified
        Chicago, Illinois, United States, 60612
      • New England Medical Center Hospital
        Not specified
        Boston, Massachusetts, United States, 02111
      • St. Elizabeth's Medical Center
        Not specified
        Boston, Massachusetts, United States, 02135-2997
      • Cancer Institute of New Jersey
        Not specified
        New Brunswick, New Jersey, United States, 08903
      • Memorial Sloan-Kettering Cancer Center
        Not specified
        New York, New York, United States, 10021
      • Mount Sinai Medical Center, NY
        Not specified
        New York, New York, United States, 10029
      • University of Pittsburgh Cancer Institute
        Not specified
        Pittsburgh, Pennsylvania, United States, 15213-3489
      • Memorial Hospital of Rhode Island
        Not specified
        Pawtucket, Rhode Island, United States, 02860
      • Rhode Island Hospital
        Not specified
        Providence, Rhode Island, United States, 02903
      • Roger Williams Medical Center/BUSM
        Not specified
        Providence, Rhode Island, United States, 02908-4735
      • Brown University Oncology Group
        Not specified
        Providence, Rhode Island, United States, 02912
      • University of Texas - MD Anderson Cancer Center
        Not specified
        Houston, Texas, United States, 77030-4009
      Status:
      unknown
      Type:
      Interventional
      Phase:
      Start:
      28 February, 1999
      Updated:
      17 December, 2013
      Participants:
      41
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