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

Sponsor

University of Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT00004127

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Duration (Months)

1.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

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 :

Feb 1, 2000

Actual Primary Completion Date :

Oct 1, 2002

Actual Study Completion Date :

Aug 1, 2003

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Clinical response rate [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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