Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have extensive-stage small cell lung cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Weekly Dose-Dense Paclitaxel in Extensive Stage Small Cell Lung Cancer|
- Response Rate [ Time Frame: 1 year post treatment ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 12 months post treatment ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 12 months post treatment ] [ Designated as safety issue: No ]
- Overall response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 1 year post treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2000|
|Study Completion Date:||February 2008|
|Primary Completion Date:||January 2004 (Final data collection date for primary outcome measure)|
Patients receive paclitaxel for up to 4 cycles. One cycle = weekly drug for 6 weeks and 2 weeks rest
150 mg/sq m IV over 3 hours weekly for 6 weeks per cycle
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.
|United States, Missouri|
|Ellis Fischel Cancer Center - Columbia|
|Columbia, Missouri, United States, 65203|
|United States, New York|
|State University of New York - Upstate Medical University|
|Syracuse, New York, United States, 13210|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center, UNC|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425-0721|
|Study Chair:||Mark A. Socinski, MD||UNC Lineberger Comprehensive Cancer Center|