Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00017082
- Lead Sponsor
- Prologue Research International
- Brief Summary
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 oxaliplatin in treating patients who have recurrent metastatic colorectal cancer.
- Detailed Description
OBJECTIVES: I. Determine the overall response rate, onset and duration of partial and complete responses, and duration of stable disease in patients with recurrent metastatic colorectal cancer treated with oxaliplatin. II. Determine the overall survival of patients treated with this drug. III. Determine the proportion of patients with tumor-related symptomatic improvement and time to tumor-related symptomatic worsening in patients treated with this drug. IV. Determine the time to disease progression in patients treated with this drug. V. Determine the proportion of patients achieving stable disease when treated with this drug. VI. Determine the safety of this drug in this patient population.
OUTLINE: This is a multicenter study. Patients receive oxaliplatin IV over 120 minutes on day 1. Courses repeat every 3 weeks for up to 1 year in the absence of disease progression. Patients are followed at 30 days and then every 8 weeks for 10 months.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
Comprehensive Cancer Care Specialists of Boca Raton
🇺🇸Boca Raton, Florida, United States
Kentuckiana Cancer Institute
🇺🇸Louisville, Kentucky, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Veterans Affairs Medical Center - Albany
🇺🇸Albany, New York, United States
Southeastern Medical Oncology Center
🇺🇸Goldsboro, North Carolina, United States
Raleigh Hematology/Oncology Associates - Wake Practice
🇺🇸Raleigh, North Carolina, United States
Pinnacle Health Hospitals
🇺🇸Harrisburg, Pennsylvania, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
Washington Cancer Institute🇺🇸Washington, District of Columbia, United States