• Objective response rate [ Designated as safety issue: No ]
  

• Clinical benefit [ Designated as safety issue: No ]
  
• Tolerability [ Designated as safety issue: Yes ]
  
• Local relapse-free survival [ Designated as safety issue: No ]
  
• Overall survival [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Determine the objective response rate in patients with metastatic esophageal cancer treated with fluorouracil, irinotecan, leucovorin calcium, and cisplatin as first-line therapy.

Secondary

• Determine the clinical benefit in patients treated with this regimen.
• Determine the tolerability of this regimen in these patients.
• Determine local relapse-free survival of patients treated with this regimen.
• Determine the overall survival of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours and cisplatin IV over 30 minutes on days 1 and 2. Treatment repeats every 15 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 1 year.

DISEASE CHARACTERISTICS:

• Histologically confirmed esophageal cancer

  • Metastatic disease

• At least 1 unidimensionally measurable metastatic lesion

  • At least 10 mm by spiral scanner OR 20 mm by sequential scanner
  • Outside the field of prior radiotherapy
• No known symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 to 75

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

Hepatic

• Bilirubin ≤ 1.5 times normal
• Alkaline phosphatase ≤ 3 times normal (5 times normal if liver metastases are present)
• SGOT and SGPT ≤ 3 times normal

Renal

• Creatinine ≤ 1.5 mg/dL

Cardiovascular

• No myocardial infarction within the past 6 months
• No uncontrolled angina

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
• No other illness or medical condition that would preclude study participation
• No psychological, social, familial, or geographical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• More than 6 months since prior fluorouracil and/or cisplatin
• No other prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• More than 6 weeks since prior radiotherapy

Surgery

• More than 4 weeks since prior surgery

Other

• No concurrent participation in another clinical study