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A Phase II Trial of MGI 114 in Patients With Advanced Pancreatic Adenocarcinoma (NCT00003760)

National Cancer Institute (NCI)
Merck Sharp & Dohme Corp.
University of Texas
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 irofulven in treating patients who have stage III or stage IV pancreatic cancer that cannot be surgically removed.
  • Drug: irofulven
    Patients receive 6-hydroxymethylacylfulvene (MGI 114) IV over 5 minutes on days 1-5. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for up to 1 year after therapy initiation.
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES: I. Determine the survival rate at 6 months of patients with stage III or IV unresectable adenocarcinoma of the pancreas treated with 6-hydroxymethylacylfulvene (MGI 114). II. Determine the objective tumor response rate, time to objective tumor response, and duration of response in these patients (if retrospective data is available, time to tumor progression while on prior gemcitabine is determined). III. Determine the clinical benefit of MGI 114 as measured by pain improvement, performance status, and weight. IV. Determine the survival rate at 3, 9, and 12 months in these patients. V. Gain additional information on the toxic effects and safety profile of this regimen.

    OUTLINE: This is an open label, multicenter study. Patients receive 6-hydroxymethylacylfulvene (MGI 114) IV over 5 minutes on days 1-5. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for up to 1 year after therapy initiation.

    PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12-18 months.

    3 locations

    United States (3)
    • University of Nebraska Medical Center
      Omaha, Nebraska, United States, 68198-3330
    • Brooke Army Medical Center
      Fort Sam Houston, Texas, United States, 78234
    • San Antonio Cancer Institute
      San Antonio, Texas, United States, 78229
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 October, 1998
    Updated:
    06 August, 2012
    Participants:
    3
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