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

Inclusion Criteria

DISEASE CHARACTERISTICS: Pathologically confirmed recurrent or extensive stage small cell
lung cancer Received at least one prior chemotherapy regimen Measurable or evaluable
disease that has not been irradiated No pleural effusions, bone metastases, brain
metastases, elevated serum enzymes, or radionuclide scans as the sole indicator lesion
Brain metastases allowed if patients received cranial irradiation and have no clinical
evidence of brain metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL PT and aPTT normal Renal:
Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min
Cardiovascular: No unstable heart rhythm No unstable angina No clinical evidence of
congestive heart failure No prior cerebrovascular accident or stroke No uncontrolled or
severe hypertension Other: Not pregnant or nursing Negative pregnancy test Fertile
patients must use effective contraception At least 6 weeks since any signs or symptoms of
bleeding No history of bleeding disorder No bacterial endocarditis or other active
infection

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks
since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks
since prior radiotherapy Surgery: At least 6 weeks since major surgery, trauma, or needle
biopsy of any organ Other: No concurrent anticoagulant or platelet inhibitor therapy