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Phase II Trial of Aminopterin in Patients With Persistent or Recurrent Endometrial Carcinoma (NCT00003821)

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 aminopterin in treating patients who have refractory or recurrent endometrial cancer.
  • Drug: aminopterin
    Ages eligible for Study
    all
    Genders eligible for Study
    Female
    Accepts Healthy Volunteers
    No
    OBJECTIVES: I. Estimate the antitumor activity of aminopterin in patients with persistent, recurrent, or refractory endometrial carcinoma who have failed prior first line cytotoxic chemotherapy. II. Determine the quantitative and qualitative toxic effects of aminopterin in this patient population. III. Determine the overall patient survival and time to progression of these patients. IV. Assess the pharmacokinetic profile of these patients.

    OUTLINE: Patients receive oral aminopterin every 12 hours twice weekly. Treatment continues for up to 15 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until death.

    PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.

    6 locations

    United States (6)
    • Division of Gynecologic Oncology
      Not specified
      Saint Louis, Missouri, United States, 63110
    • East Carolina University School of Medicine
      Not specified
      Greenville, North Carolina, United States, 27858-4354
    • Gynecologic Oncologists of NE Ohio
      Not specified
      Akron, Ohio, United States, 44302
    • Simmons Cancer Center - Dallas
      Not specified
      Dallas, Texas, United States, 75235-9154
    • Texas Oncology, P.A.
      Not specified
      Dallas, Texas, United States, 75246
    • University of Wisconsin Comprehensive Cancer Center
      Not specified
      Madison, Wisconsin, United States, 53792
    Status:
    unknown
    Type:
    Interventional
    Phase:
    Start:
    31 December, 1997
    Updated:
    02 January, 2014
    Participants:
    25
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