Clinical trial · Interventional
Lepirudin in Treating Patients With Recurrent or Advanced Small Cell Lung Cancer
A Phase I/II Study of Recombinant Desulfato Hirudin, Lepirudin (Refludan) in Small Cell Lung Cancer Patients Previously Treated With Chemotherapy
NCT00003726CI-TRIAL-00023386terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study funding was dropped.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lepirudin | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lepirudin
- description
- 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)
- interventionNames
- Biological: lepirudin
Primary outcomes (1)
- measure
- Dose, Safety and Antitumor Response Rate of Administering Recombinant Desulfato Hirudin, Elpirudin to Previously Treated Patients With Extensive or Recurrent Small Cell Lung Cancer
- timeFrame
- 18 months
- description
- Evaluated through clinical exams, tumor assessments, laboratory assessment, and adverse event assessments.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: 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 PRIOR CONCURRENT THERAPY: 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
References
Publications (0)
Data not yet available
No reference posted for this study.