Little Rock,
Arkansas
72205
Purpose:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Chemoprotective drugs such as triacetyluridine may protect
normal cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of triacetyluridine, fluorouracil, and
leucovorin in treating patients who have unresectable, locally advanced, or metastatic
cancer of the esophagus or stomach.
Study summary:
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.
Criteria:
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