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Lepirudin in Treating Patients With Recurrent or Advanced Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsored by: Norris Cotton Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003726
  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 I
Phase II

Study Type: Interventional
Study Design: 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 National Cancer Institute (NCI):

Estimated Enrollment: 35
Study Start Date: November 1998
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

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
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
Norris Cotton Cancer Center
Investigators
Study Chair: James R. Rigas, MD Norris Cotton Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000066838, DMS-9815, NCI-V98-1512
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003726     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
extensive stage small cell lung cancer
recurrent small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Anticoagulants
Carcinoma, Neuroendocrine
Fibrinolytic Agents
Cardiovascular Agents
Recurrence
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Fibrin Modulating Agents
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Lepirudin
Hirudins
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Molecular Mechanisms of Pharmacological Action
Neoplasms, Nerve Tissue
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Anticoagulants
Cardiovascular Agents
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Lung Diseases
Adenocarcinoma
Lepirudin
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 01, 2009