Lung Cancer Clinical Trial
Official title:
A Phase I/II Study of Recombinant Desulfato Hirudin, Lepirudin (Refludan) in Small Cell Lung Cancer Patients Previously Treated With Chemotherapy
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.
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.
;
Primary Purpose: Treatment
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