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A Phase II Study of Oxaliplatin in Combination With Fluorouracil and Leucovorin in Carcinoma of the Esophagus and Gastric Cardia

Phase 2
18 Years
Not Enrolling
Esophageal Cancer, Gastric Cancer

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Trial Information

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.

Inclusion 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical response rate

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Ann M. Mauer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

August 2003

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • stage IV esophageal cancer
  • recurrent esophageal cancer
  • adenocarcinoma of the stomach
  • adenocarcinoma of the esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



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