Esophageal Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

35

Study ID:

NCT00004127

Recruitment Status:

Completed

Sponsor:

University of Chicago

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 22 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

35

Study ID:

NCT00004127

Recruitment Status:

Completed

Sponsor:


University of Chicago

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider