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A Phase I/II Study of Recombinant Desulfato Hirudin, Lepirudin (Refludan) in Small Cell Lung Cancer Patients Previously Treated With Chemotherapy (NCT00003726)

National Cancer Institute (NCI)
RATIONALE: Anticoagulants, such as lepirudin, may help prevent blood clots from forming in patients who have received chemotherapy for small cell lung cancer. PURPOSE: This phase I/II trial is studying the side effects and best dose of lepirudin in treating patients with recurrent or advanced small cell lung cancer.
  • Biological: lepirudin
    lepirudin
    Ages eligible for Study
    18 Years to 120 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES: I. Determine the dose, safety, and antitumor response rate of lepirudin in patients with recurrent or extensive stage small cell lung cancer previously treated with chemotherapy.

    OUTLINE: This is a dose escalation (in individual patients) study. Patients receive dose escalated lepirudin subcutaneously once or twice a day for 3-4 days. Dose escalation continues in each patient until aPTT prolongation occurs or the maximum dose level is reached. The patient then continues treatment on the maximum tolerated dose. Treatment continues in the absence of disease progression or unacceptable toxicity.

    PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 18-24 months.

    1 locations

    United States (1)
    • Norris Cotton Cancer Center
      Not specified
      Lebanon, New Hampshire, United States, 03756
    Participant Flow: Overall Study
    Lepirudin
    Serious Adverse Events
    Lepirudin
    Other Adverse Events
    Lepirudin
    Status:
    terminated
    Type:
    Interventional
    Phase:
    Ⅰ, Ⅱ
    Start:
    31 October, 1998
    Updated:
    26 June, 2016
    Participants:
    1
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