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A Phase I/II Study of Recombinant Desulfato Hirudin, Lepirudin (Refludan) in Small Cell Lung Cancer Patients Previously Treated With Chemotherapy


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase I/II Study of Recombinant Desulfato Hirudin, Lepirudin (Refludan) in Small Cell Lung Cancer Patients Previously Treated With Chemotherapy


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

James R. Rigas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Norris Cotton Cancer Center

Authority:

United States: Federal Government

Study ID:

D9815

NCT ID:

NCT00003726

Start Date:

November 1998

Completion Date:

July 2001

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Norris Cotton Cancer CenterLebanon, New Hampshire  03756