Spots Global Cancer Trial Database for Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer
Official Title: Phase II Trial of LE SN38 in Patients With Metastatic Colorectal Cancer After Progression on Oxaliplatin
Study ID: NCT00311610
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: Primary * Determine the objective response rate following treatment with SN-38 liposome as a second-line treatment in patients with metastatic colorectal cancer. Secondary * 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Kaiser Permanente Medical Office -Vandever Medical Office, San Diego, California, United States
Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Union Hospital Cancer Program at Union Hospital, Elkton MD, Maryland, United States
University Medical Center of Southern Nevada, Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
Kinston Medical Specialists, Kinston, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States
Contact Details
Name: Allyson Ocean, MD
Affiliation: Weill Medical College of Cornell University
Role: STUDY_CHAIR
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