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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00003726
First received: November 1, 1999
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Lung Cancer
Biological: lepirudin
Phase 1
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Estimated Enrollment: 35
Study Start Date: November 1998
Study Completion Date: July 2001
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003726

Locations
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Study Chair: James R. Rigas, MD Norris Cotton Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00003726     History of Changes
Other Study ID Numbers: D9815, P30CA023108, DMS-9815, NCI-V98-1512
Study First Received: November 1, 1999
Last Updated: January 8, 2013
Health Authority: United States: Federal Government

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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lepirudin
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014