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Oxaliplatin Combined With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach

This study has been completed.

Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004127
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Phase II

MedlinePlus related topics:   Cancer    Esophageal Cancer    Esophagus Disorders    Stomach Cancer   

Drug Information available for:   Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Fluorouracil    Oxaliplatin    Calcium gluconate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Study of Oxaliplatin in Combination With Fluorouracil and Leucovorin in Carcinoma of the Esophagus and Gastric Cardia

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   February 2000

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed carcinoma of the esophagus or gastric cardia Stage IV or recurrent Bidimensionally measurable disease

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004127

Locations
United States, Connecticut
Yale Comprehensive Cancer Center    
      New Haven, Connecticut, United States, 06520-8028
United States, Illinois
Cancer Care Specialists of Central Illinois, S.C.    
      Decatur, Illinois, United States, 62526
Central Illinois Hematology Oncology Center    
      Springfield, Illinois, United States, 62701
Columbia LaGrange Memorial Hospital    
      LaGrange, Illinois, United States, 60525
Evanston Northwestern Health Care    
      Evanston, Illinois, United States, 60201
University of Chicago Cancer Research Center    
      Chicago, Illinois, United States, 60637-1470
Louis A. Weiss Memorial Hospital    
      Chicago, Illinois, United States, 60640
Loyola University Medical Center    
      Maywood, Illinois, United States, 60153
Lutheran General Cancer Care Center    
      Park Ridge, Illinois, United States, 60068
Oncology/Hematology Associates of Central Illinois, P.C.    
      Peoria, Illinois, United States, 61602
Ingalls Memorial Hospital    
      Harvey, Illinois, United States, 60426
University of Illinois at Chicago    
      Chicago, Illinois, United States, 60612
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Inc.    
      Fort Wayne, Indiana, United States, 46885-5099
Michiana Hematology/Oncology P.C.    
      South Bend, Indiana, United States, 46617
United States, Kentucky
Central Baptist Hospital    
      Lexington, Kentucky, United States, 40503
United States, Michigan
Lakeland Medical Center - St. Joseph    
      Saint Joseph, Michigan, United States, 49085
University of Michigan Comprehensive Cancer Center    
      Ann Arbor, Michigan, United States, 48109-0752
United States, New York
Roswell Park Cancer Institute    
      Buffalo, New York, United States, 14263-0001
United States, Ohio
Cleveland Clinic Taussig Cancer Center    
      Cleveland, Ohio, United States, 44195
Grant/Riverside Methodist Hospitals    
      Columbus, Ohio, United States, 43214
United States, South Carolina
Cancer Centers of the Carolinas    
      Greenville, South Carolina, United States, 29605
Puerto Rico
University of Puerto Rico School of Medicine Medical Sciences Campus    
      San Juan, Puerto Rico, 00936-5067

Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)

Investigators
Study Chair:     Ann M. Mauer, MD     University of Chicago    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067355, UCCRC-10015, NCI-T99-0010
First Received:   December 10, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004127
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV gastric cancer  
recurrent gastric cancer  
stage IV esophageal cancer  
recurrent esophageal cancer
adenocarcinoma of the stomach
adenocarcinoma of the esophagus

Study placed in the following topic categories:
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Leucovorin
Stomach cancer
Recurrence
Carcinoma
Oxaliplatin
Digestive System Diseases
Stomach Diseases
Fluorouracil
Stomach Neoplasms
Head and Neck Neoplasms
Neoplasm Metastasis
Gastrointestinal Neoplasms
Esophageal Diseases
Adenocarcinoma
Esophageal neoplasm

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on November 20, 2008




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