Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer
- Registration Number
- NCT00311610
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SN-38 liposome SN-38 liposome 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.
- Primary Outcome Measures
Name Time Method Objective response rate q 2 cycles during tx
- Secondary Outcome Measures
Name Time Method Toxicity q cycle during tx Progression-free survival 3 years Overall survival 3 years
Trial Locations
- Locations (10)
Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Kaiser Permanente Medical Office -Vandever Medical Office
🇺🇸San Diego, California, United States
Union Hospital Cancer Program at Union Hospital
🇺🇸Elkton MD, Maryland, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, 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
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States