Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Multicenter, Phase II Study Of Oxaliplatin Single Agent As Third-Line Treatment Of Metastatic Colorectal Carcinoma|
|Study Start Date:||April 2001|
|Study Completion Date:||December 2010|
|Primary Completion Date:||June 2003 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017082
|United States, District of Columbia|
|Washington Cancer Institute|
|Washington, District of Columbia, United States, 20010|
|United States, Florida|
|Comprehensive Cancer Care Specialists of Boca Raton|
|Boca Raton, Florida, United States, 33428|
|United States, Kentucky|
|Kentuckiana Cancer Institute|
|Louisville, Kentucky, United States, 40202|
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-3330|
|United States, New York|
|Veterans Affairs Medical Center - Albany|
|Albany, New York, United States, 12208|
|United States, North Carolina|
|Southeastern Medical Oncology Center|
|Goldsboro, North Carolina, United States, 27534|
|Raleigh Hematology/Oncology Associates - Wake Practice|
|Raleigh, North Carolina, United States, 27609|
|United States, Pennsylvania|
|Pinnacle Health Hospitals|
|Harrisburg, Pennsylvania, United States, 17105-8700|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|United States, Tennessee|
|Memphis Cancer Center|
|Memphis, Tennessee, United States, 38119|
|Study Chair:||Richard A. Gams, MD||Prologue Research International|