Lepirudin in Treating Patients With Recurrent or Advanced Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Biological: lepirudin Phase 1 Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lepirudin
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)
Biological: lepirudin

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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


  1. Age: Not specified
  2. Performance status: Karnofsky 60-100%
  3. Life expectancy: Not specified
  4. Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
  5. Hepatic: Bilirubin no greater than 2.0 mg/dL PT and aPTT normal
  6. Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min
  7. 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
  8. Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
  9. At least 6 weeks since any signs or symptoms of bleeding No history of bleeding disorder
  10. No bacterial endocarditis or other active infection


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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00003726

United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Study Chair: James R. Rigas, MD Norris Cotton Cancer Center

Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT00003726     History of Changes
Other Study ID Numbers: D9815
P30CA023108 ( U.S. NIH Grant/Contract )
DMS-9815 ( Other Identifier: Dartmouth-Hitchcock Medical Center )
NCI-V98-1512 ( Other Identifier: NCI )
First Posted: May 3, 2004    Key Record Dates
Results First Posted: August 8, 2016
Last Update Posted: August 8, 2016
Last Verified: June 2016

Keywords provided by Dartmouth-Hitchcock Medical Center:
extensive stage small cell lung cancer
recurrent small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents