A Phase II Study of Oxaliplatin in Combination With Fluorouracil and Leucovorin in Carcinoma of the Esophagus and Gastric Cardia
OBJECTIVES: I. Determine the response rate in patients with recurrent or metastatic
carcinoma of the esophagus or gastric cardia receiving the combination of oxaliplatin,
fluorouracil, and leucovorin calcium. II. Determine the duration of response and overall
survival of this patient population receiving this regimen. III. Determine the toxicity,
including neurotoxicity, of this regimen in this patient population.
OUTLINE: This is an open-label, multicenter study. Patients receive oxaliplatin IV over 2
hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed
by fluorouracil IV over 22 hours on days 1 and 2. Treatment continues every 2 weeks for a
minimum of 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with stable or responding disease receive at least 3 additional courses of therapy.
Patients are followed for a minimum of 2 years or until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study over 18 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical response rate
Ann M. Mauer, MD
University of Chicago
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Yale Comprehensive Cancer Center||New Haven, Connecticut 06520-8028|
|Loyola University Medical Center||Maywood, Illinois 60153|
|Ingalls Memorial Hospital||Harvey, Illinois 60426|
|Lutheran General Cancer Care Center||Park Ridge, Illinois 60068|
|Evanston Northwestern Health Care||Evanston, Illinois 60201|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Louis A. Weiss Memorial Hospital||Chicago, Illinois 60640|
|Lakeland Medical Center - St. Joseph||Saint Joseph, Michigan 49085|
|University of Illinois at Chicago||Chicago, Illinois 60612|
|Central Baptist Hospital||Lexington, Kentucky 40503|
|Cancer Care Specialists of Central Illinois, S.C.||Decatur, Illinois 62526|
|Oncology/Hematology Associates of Central Illinois, P.C.||Peoria, Illinois 61602|
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|Fort Wayne Medical Oncology and Hematology, Inc.||Fort Wayne, Indiana 46885-5099|
|Michiana Hematology/Oncology P.C.||South Bend, Indiana 46617|
|Grant/Riverside Methodist Hospitals||Columbus, Ohio 43214|
|Cancer Centers of the Carolinas||Greenville, South Carolina 29605|
|Columbia LaGrange Memorial Hospital||LaGrange, Illinois 60525|