A Phase I/II Study of Recombinant Desulfato Hirudin, Lepirudin (Refludan) in Small Cell Lung Cancer Patients Previously Treated With Chemotherapy
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.
Interventional
Primary Purpose: Treatment
James R. Rigas, MD
Study Chair
Norris Cotton Cancer Center
United States: Federal Government
D9815
NCT00003726
November 1998
July 2001
Name | Location |
---|---|
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |