Lung Cancer Clinical Trial
Lepirudin in Treating Patients With Recurrent or Advanced Small Cell Lung Cancer
Summary
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.
Full Description
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.
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Lebanon New Hampshire, 03756, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.