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A Phase II Study of Gemcitabine and Docetaxel in Pancreatic Adenocarcinoma (NCT00003810)

National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more that one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and docetaxel in treating patients who have locally advanced or metastatic cancer of the pancreas.
  • Drug: docetaxel
    • Drug: gemcitabine hydrochloride
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      OBJECTIVES: I. Determine the objective response rate of patients with pancreatic adenocarcinoma treated with combination gemcitabine and docetaxel. II. Determine the toxicity profile of this combination therapy in these patients. III. Assess the survival rate of these patients.

      OUTLINE: Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes. Patients receive treatment every other week for 8 weeks (4 courses). Patients may continue treatment in the absence of unacceptable toxicity or disease progression. Patients are followed every 12 weeks until death.

      PROJECTED ACCRUAL: This study will accrue approximately 10 patients per month for a maximum of 33 patients.

      10 locations

      United States (10)
      • Indiana University Cancer Center
        Indianapolis, Indiana, United States, 46202-5265
      • Greater Baltimore Medical Center and Cancer Center
        Baltimore, Maryland, United States, 21204
      • Johns Hopkins Oncology Center
        Baltimore, Maryland, United States, 21287
      • New England Medical Center Hospital
        Boston, Massachusetts, United States, 02111
      • Beth Israel Deaconess Medical Center
        Boston, Massachusetts, United States, 02215
      • CCOP - Missouri Valley Cancer Consortium
        Omaha, Nebraska, United States, 68131
      • Veterans Affairs Medical Center - Nashville
        Nashville, Tennessee, United States, 37212
      • Vanderbilt Cancer Center
        Nashville, Tennessee, United States, 37232-6838
      • Veterans Affairs Medical Center - Madison
        Madison, Wisconsin, United States, 53705
      • University of Wisconsin Comprehensive Cancer Center
        Madison, Wisconsin, United States, 53792
      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      31 March, 1999
      Updated:
      21 August, 2013
      Participants:
      0
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