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

Phase 1

Terminated

• Conditions: Lung Cancer
• Interventions: Biological: lepirudin

• Registration Number: NCT00003726
• Lead Sponsor: 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.

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 Timeline

• Study Start: 1998-11
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-07
• Study Completion: 2001-07
• Study First Submitted QC: 2004-04-30
• Study First Posted: 2004-05-03
• Results First Submitted: 2013-05-16
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-27
• Last Update Submitted: 2016-06-27
• Results First Posted: 2016-08-08
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lepirudin	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)

Primary Outcome Measures

Name	Time	Method
Dose, Safety and Antitumor Response Rate of Administering Recombinant Desulfato Hirudin, Elpirudin to Previously Treated Patients With Extensive or Recurrent Small Cell Lung Cancer	18 months	Evaluated through clinical exams, tumor assessments, laboratory assessment, and adverse event assessments.

Trial Locations

Locations (1)

Norris Cotton Cancer Center; 🇺🇸 Lebanon, New Hampshire, United States