A Multicenter, Phase II Study Of Oxaliplatin Single Agent As Third-Line Treatment Of Metastatic Colorectal Carcinoma
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.
Primary Purpose: Treatment
Richard A. Gams, MD
Prologue Research International
United States: Federal Government
|University of Pennsylvania Cancer Center||Philadelphia, Pennsylvania 19104|
|Veterans Affairs Medical Center - Albany||Albany, New York 12208|
|University of Nebraska Medical Center||Omaha, Nebraska 68198-3330|
|Pinnacle Health Hospitals||Harrisburg, Pennsylvania 17105-8700|
|Washington Cancer Institute||Washington, District of Columbia 20010|
|Southeastern Medical Oncology Center||Goldsboro, North Carolina 27534|
|Comprehensive Cancer Care Specialists of Boca Raton||Boca Raton, Florida 33428|
|Raleigh Hematology/Oncology Associates - Wake Practice||Raleigh, North Carolina 27609|
|Memphis Cancer Center||Memphis, Tennessee 38119|
|Kentuckiana Cancer Institute||Louisville, Kentucky 40202|