Phase II Trial of LE SN38 in Patients With Metastatic Colorectal Cancer After Progression on Oxaliplatin
- Determine the objective response rate following treatment with SN-38 liposome as a
second-line treatment in patients with metastatic colorectal cancer.
- Determine the toxicity profile of this drug in these patients.
- Determine the proportion of patients treated with this drug who experience any grade 3
or greater toxicity.
- Determine progression-free survival and overall survival for patients treated with this
OUTLINE: This is a multicenter study.
Patients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for up to 3 years.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate
q 2 cycles during tx
Allyson J. Ocean, MD
Weill Medical College of Cornell University
United States: Food and Drug Administration
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|CCOP - Nevada Cancer Research Foundation||Las Vegas, Nevada 89109-2306|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|
|University Medical Center of Southern Nevada||Las Vegas, Nevada 89102|
|Kaiser Permanente Medical Office -Vandever Medical Office||San Diego, California 92120|
|Cancer Institute of New Jersey at Cooper - Voorhees||Voorhees, New Jersey 08043|
|Tunnell Cancer Center at Beebe Medical Center||Lewes, Delaware 19958|
|Union Hospital Cancer Program at Union Hospital||Elkton MD, Maryland 21921|
|Kinston Medical Specialists||Kinston, North Carolina 28501|