S9915 Triacetyluridine, Fluorouracil, and Leucovorin in Treating Patients With Unresectable, Locally Advanced, or Metastatic Cancer of the Esophagus or Stomach

OBJECTIVES:

• Assess the 6-month survival rate in patients with unresectable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with triacetyluridine, fluorouracil, and leucovorin calcium.
• Evaluate the qualitative and quantitative toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 30 minutes beginning 1 hour into leucovorin calcium infusion on days 1, 8, 15, 22, 29, and 36. Patients receive oral triacetyluridine every 8 hours on days 1-3, 8-10, 15-17, 22-24, 29-31, and 36-38 beginning 8 hours after completion of each fluorouracil infusion. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven unresectable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction
• No known brain metastases

• Negative brain imaging required for neurologic signs and symptoms

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin no greater than upper limit of normal (ULN)
• SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver tumor present)

Renal:

• Creatinine no greater than ULN

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• Must be able to swallow oral medication
• No AIDS syndrome or HIV-associated complex
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy
• No concurrent biologic therapy

Chemotherapy:

• No prior chemotherapy for advanced or metastatic gastric cancer
• At least 6 months since prior chemotherapy as adjuvant or radiation sensitizer

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 1 month since prior radiotherapy and recovered
• No concurrent radiotherapy

Surgery:

• At least 3 weeks since prior major surgical resection of intra-abdominal organs and recovered