A Phase II Study of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU), and Leucovorin (CF) in Patients With Metastatic Colorectal Carcinoma Previously Treated With Irinotecan (CPT-11)
I. Determine the tumor response rate in patients treated with oxaliplatin, fluorouracil, and
leucovorin calcium for metastatic colorectal cancer previously treated with irinotecan.
II. Determine the time to tumor progression, time to treatment failure, and overall survival
of patients treated with this regimen.
III. Determine the toxicity of this regimen in this patient population. IV. Assess the
quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium and
fluorouracil IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of
disease progression or unacceptable toxicity. Patients achieving a confirmed complete
response for 2 consecutive courses may discontinue study treatment at the investigators
discretion. Quality of life is assessed at baseline, approximately every 6-8 weeks during
treatment, and then after the last course of treatment. Patients are followed every 3 months
for 5 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Henry C. Pitot, MD
United States: Food and Drug Administration
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Ann Arbor Regional||Ann Arbor, Michigan 48106|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Illinois Oncology Research Association||Peoria, Illinois 61602|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Duluth||Duluth, Minnesota 55805|
|CCOP - Scottsdale Oncology Program||Scottsdale, Arizona 85259-5404|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|Siouxland Hematology-Oncology||Sioux City, Iowa 51101-1733|
|CCOP - Ochsner||New Orleans, Louisiana 70121|
|CentraCare Clinic||Saint Cloud, Minnesota 56303|
|CCOP - Merit Care Hospital||Fargo, North Dakota 58122|
|Altru Health Systems||Grand Forks, North Dakota 58201|
|CCOP - Toledo Community Hospital Oncology Program||Toledo, Ohio 43623-3456|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|CCOP - Sooner State||Tulsa, Oklahoma 74136|
|Medcenter One Health System||Bismarck, North Dakota 58501|
|Oncology Associates of Cedar Rapids||Cedar Rapids, Iowa 52403|