Lepirudin in Treating Patients With Recurrent or Advanced Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00003726|
Recruitment Status : Terminated (Study funding was dropped.)
First Posted : May 3, 2004
Results First Posted : August 8, 2016
Last Update Posted : August 8, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: lepirudin||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Recombinant Desulfato Hirudin, Lepirudin (Refludan) in Small Cell Lung Cancer Patients Previously Treated With Chemotherapy|
|Study Start Date :||November 1998|
|Primary Completion Date :||July 2001|
|Study Completion Date :||July 2001|
Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
- Dose, Safety and Antitumor Response Rate of Administering Recombinant Desulfato Hirudin, Elpirudin to Previously Treated Patients With Extensive or Recurrent Small Cell Lung Cancer [ Time Frame: 18 months ]Evaluated through clinical exams, tumor assessments, laboratory assessment, and adverse event assessments.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003726
|United States, New Hampshire|
|Norris Cotton Cancer Center|
|Lebanon, New Hampshire, United States, 03756|
|Study Chair:||James R. Rigas, MD||Norris Cotton Cancer Center|