Oxaliplatin Combined With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach
NCT ID: NCT00004127
Last Updated: 2013-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2000-02-29
2003-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A
Oxaliplatin (85 mg/m2, day 1 of every 14 day cycle), Leucovorin (500 mg/m2, day 1 and 2 of every 14 day cycle), Fluorouracil (Bolus of 400 mg/m2 followed by 22 hr continuous infusion of 600 mg/m2 on days 1 and 2 of every 14 day cycle)
FOLFOX regimen
fluorouracil
leucovorin calcium
oxaliplatin
Interventions
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FOLFOX regimen
fluorouracil
leucovorin calcium
oxaliplatin
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin normal SGOT less than 2 times upper limit of normal (ULN) Renal: BUN less than 1.5 times ULN Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No congestive heart failure No unstable angina pectoris No myocardial infarction within the past 6 months Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 6 months after study No allergy to platinum compounds or antiemetics appropriate for study No uncontrolled concurrent illness No active infection No clinical evidence of peripheral neuropathy by physical exam or history
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony-stimulating factors during the first course of study Chemotherapy: More than 4 weeks since prior chemotherapy No more than 1 prior chemotherapy regimen for carcinoma of the esophagus or gastric cardia No prior fluorouracil Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents No concurrent antiretroviral therapy in HIV-positive patients No other concurrent anticancer agents
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Ann M. Mauer, MD
Role: STUDY_CHAIR
University of Chicago
Locations
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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
Countries
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Other Identifiers
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UCCRC-10015
Identifier Type: -
Identifier Source: secondary_id
NCI-T99-0010
Identifier Type: -
Identifier Source: secondary_id
10015
Identifier Type: -
Identifier Source: org_study_id
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