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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004127
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : February 11, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastric Cancer Drug: FOLFOX regimen Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Oxaliplatin in Combination With Fluorouracil and Leucovorin in Carcinoma of the Esophagus and Gastric Cardia
Study Start Date : February 2000
Actual Primary Completion Date : October 2002
Actual Study Completion Date : August 2003

Arm Intervention/treatment
Experimental: 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)
Drug: FOLFOX regimen
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin

Primary Outcome Measures :
  1. Clinical response rate [ Time Frame: 3 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004127

United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, United States, 62526
Evanston Northwestern Health Care
Evanston, Illinois, United States, 60201
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Columbia LaGrange Memorial Hospital
LaGrange, Illinois, United States, 60525
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
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
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
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, United States, 49085
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)
Study Chair: Ann M. Mauer, MD University of Chicago

Responsible Party: University of Chicago Identifier: NCT00004127     History of Changes
Other Study ID Numbers: 10015
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: February 2013

Keywords provided by University of Chicago:
stage IV gastric cancer
recurrent gastric cancer
stage IV esophageal cancer
recurrent esophageal cancer
adenocarcinoma of the stomach
adenocarcinoma of the esophagus

Additional relevant MeSH terms:
Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents