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A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Metastatic Carcinoma of the Pancreas (NCT00003951)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have metastatic cancer of the pancreas that has not been previously treated or that has not responded to previous chemotherapy.
  • Drug: exatecan mesylate
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES: I. Determine the objective response rate in patients with metastatic carcinoma of the exocrine pancreas treated with DX-8951f. II. Determine the time to tumor progression in patients receiving this drug. III. Determine the survival at 6 and 12 months of patients receiving this drug. IV. Evaluate the quantitative and qualitative toxicities of this regimen in this patient population. V. Evaluate the pharmacokinetics of this drug in this patient population.

    OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until death.

    PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.

    3 locations

    United States (3)
    • Johns Hopkins Oncology Center
      Not specified
      Baltimore, Maryland, United States, 21287
    • Memorial Sloan-Kettering Cancer Center
      Not specified
      New York, New York, United States, 10021
    • University of Texas Health Science Center at San Antonio
      Not specified
      San Antonio, Texas, United States, 78284
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 May, 1999
    Updated:
    14 May, 2012
    Participants:
    37
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