Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy, such as liposomal SN-38, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well liposomal SN-38 works in treating patients with metastatic colorectal cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of LE SN38 in Patients With Metastatic Colorectal Cancer After Progression on Oxaliplatin|
- Objective response rate [ Time Frame: q 2 cycles during tx ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: q cycle during tx ] [ Designated as safety issue: Yes ]
- Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Study Completion Date:||June 2010|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
Drug: SN-38 liposome
- 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 drug.
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.
|United States, California|
|Kaiser Permanente Medical Office -Vandever Medical Office|
|San Diego, California, United States, 92120|
|United States, Delaware|
|Tunnell Cancer Center at Beebe Medical Center|
|Lewes, Delaware, United States, 19958|
|CCOP - Christiana Care Health Services|
|Newark, Delaware, United States, 19713|
|United States, Maryland|
|Union Hospital Cancer Program at Union Hospital|
|Elkton MD, Maryland, United States, 21921|
|United States, Nevada|
|CCOP - Nevada Cancer Research Foundation|
|Las Vegas, Nevada, United States, 89106|
|University Medical Center of Southern Nevada|
|Las Vegas, Nevada, United States, 89102|
|United States, New Jersey|
|Cancer Institute of New Jersey at Cooper - Voorhees|
|Voorhees, New Jersey, United States, 08043|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Kinston Medical Specialists|
|Kinston, North Carolina, United States, 28501|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210-1240|
|Study Chair:||Allyson J. Ocean, MD||Weill Medical College of Cornell University|