Phase II Trial of Weekly Dose-Dense Paclitaxel in Extensive Stage Small Cell Lung Cancer
OBJECTIVES: I. Determine the complete and overall response rate to paclitaxel in patients
with previously untreated extensive stage small cell lung cancer. II. Determine the overall
and progression free survival of these patients in response to this treatment regimen. III.
Determine the toxicity of this treatment regimen in this patient population.
OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours weekly for
6 consecutive weeks. Treatment continues every 8 weeks for 4 courses in the absence of
disease progression or unacceptable toxicity. Patients are followed every 2 months for 1
year, then every 3 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study over 8-11 months.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1 year post treatment
Mark A. Socinski, MD
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
|Lineberger Comprehensive Cancer Center, UNC||Chapel Hill, North Carolina 27599-7295|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Medical University of South Carolina||Charleston, South Carolina 29425-0721|
|Ellis Fischel Cancer Center - Columbia||Columbia, Missouri 65203|
|State University of New York - Upstate Medical University||Syracuse, New York 13210|