Phase II Study Of BBR 3464 As Treatment In Patients With Sensitive Or Refractory Small Cell Lung Cancer After One Prior Chemotherapy Regimen
OBJECTIVES: I. Determine the efficacy of BBR 3464 in terms of response rate in patients with
sensitive or refractory metastatic small cell lung cancer. II. Determine the duration of
response and time to progression in patients treated with this drug. III. Determine the
overall survival of patients treated with this drug. IV. Determine the incidence and
severity of toxic effects of this drug in this patient population. V. Determine the
pharmacokinetics of this drug in this patient population.
OUTLINE: This is a multicenter study. Patients are stratified according to disease
(refractory vs sensitive). Patients receive BBR 3464 IV over 1 hour on day 1. Treatment
repeats every 21 days for at least 3 courses in the absence of disease progression or
unacceptable toxicity. Patients with complete or partial response or stable disease may
receive up to 6 courses of therapy. Patients without progressive disease after 6 courses may
continue treatment at the investigator's discretion. Patients are followed every 9 weeks for
3 years.
PROJECTED ACCRUAL: A total of 24-74 patients (12-37 per stratum) will be accrued for this
study.
Interventional
Primary Purpose: Treatment
Mark A. Socinski, MD
Study Chair
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
CDR0000068555
NCT00014547
November 2000
Name | Location |
---|---|
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
Massey Cancer Center | Richmond, Virginia 23298-0037 |
Washington University Barnard Cancer Center | Saint Louis, Missouri 63110 |
Michiana Hematology/Oncology P.C. | South Bend, Indiana 46617 |
Highlands Oncology Group, P.A. | Fayetteville, Arkansas 72703 |
Oklahoma Oncology Inc. | Tulsa, Oklahoma 74104 |
Louisiana Oncology Associates | Lafayette, Louisiana 70506 |
Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
Cancer Services | Columbus, Ohio 43214 |
Theradex | Princeton, New Jersey 08543 |
Clinical Research Consultants, Inc | Hoover, Alabama 35216 |
Office of Peter D. Byeff | Southington, Connecticut 06489 |
Indiana Cancer Pavilion | Indianapolis, Indiana 46202 |
University Hospital Lexington | Lexington, Kentucky 40536-0084 |