TerminatedPhase 1 / Phase 2NCT00003726

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

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.

Checked against the public recordLast updated Aug 8, 2016 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 1 / Phase 2
U.S. locations1
SponsorDartmouth-Hitchcock Medical Center
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Dartmouth-Hitchcock Medical Center
Interventions being studied
Biological: lepirudin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Norris Cotton Cancer CenterLebanon, New Hampshire

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 8, 2016. Always confirm current availability with the study team.

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