Spots Global Cancer Trial Database for Oxaliplatin Combined With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach
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Trial Identification
Brief Title: Oxaliplatin Combined With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach
Official Title: A Phase II Study of Oxaliplatin in Combination With Fluorouracil and Leucovorin in Carcinoma of the Esophagus and Gastric Cardia
Study ID: NCT00004127
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with fluorouracil and leucovorin in treating patients who have recurrent or metastatic cancer of the esophagus or stomach.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Yale Comprehensive Cancer Center, New Haven, Connecticut, United States
University of Illinois at Chicago, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital, Chicago, Illinois, United States
Cancer Care Specialists of Central Illinois, S.C., Decatur, Illinois, United States
Evanston Northwestern Health Care, Evanston, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Columbia LaGrange Memorial Hospital, LaGrange, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Lutheran General Cancer Care Center, Park Ridge, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C., Peoria, Illinois, United States
Central Illinois Hematology Oncology Center, Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne, Indiana, United States
Michiana Hematology/Oncology P.C., South Bend, Indiana, United States
Central Baptist Hospital, Lexington, Kentucky, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Lakeland Medical Center - St. Joseph, Saint Joseph, Michigan, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Grant/Riverside Methodist Hospitals, Columbus, Ohio, United States
Cancer Centers of the Carolinas, Greenville, South Carolina, United States
University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan, , Puerto Rico
Contact Details
Name: Ann M. Mauer, MD
Affiliation: University of Chicago
Role: STUDY_CHAIR
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