Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer

DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed adenocarcinoma of the pancreas

  * Unresectable locally advanced or metastatic disease

    * Stage II, III, or IV
* Measurable or evaluable disease
* No elevated tumor marker (CA 19-9) only
* No clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion)
* No carcinoid, islet cell, or lymphoma of the pancreas
* No prior or concurrent brain or leptomeningeal metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 70-100%

Life expectancy:

* At least 3 months

Hematopoietic:

* WBC at least 3,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.5 g/dL

Hepatic:

* Bilirubin no greater than 2.0 mg/dL
* ALT or AST less than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
* No uncontrolled hepatic dysfunction

Renal:

* Creatinine less than 2.0 mg/dL
* No uncontrolled renal dysfunction

Cardiovascular:

* No uncontrolled cardiovascular disease requiring therapy, including the following:

  * Angina
  * Arrhythmias
  * Uncompensated cardiac failure
  * Myocardial infarction within the past 6 months

Pulmonary:

* No uncontrolled pulmonary dysfunction

Gastrointestinal:

* Able to take and/or retain oral medication
* No uncontrolled malabsorption syndrome or any other condition that would interfere with intestinal absorption

Other:

* No known allergy to fluorouracil (5-FU), gemcitabine, triacetyluridine, or any of their components
* No dihydropyrimidine-dehydrogenase deficiency
* No active uncontrolled infection
* No uncontrolled neurologic or psychiatric dysfunction
* No other malignancy except previously resected basal cell cancer or curatively resected stage I or less cervical cancer that has been disease free for at least 5 years
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent biologic therapy (including immunotherapy) for cancer

Chemotherapy:

* No prior chemotherapy for cancer other than as a radiosensitizer
* No prior 5-FU or gemcitabine other than as a radiosensitizer
* No prior triacetyluridine
* No other concurrent chemotherapy (including leucovorin calcium) for cancer

Endocrine therapy:

* No concurrent hormonal therapy for cancer
* Concurrent megestrol, oral contraceptives, or postmenopausal estrogen replacement therapy allowed

Radiotherapy:

* Prior radiotherapy allowed
* No concurrent radiotherapy

Surgery:

* See Disease Characteristics
* Prior resection of pancreas allowed

Other:

* At least 30 days since prior investigational drug or therapeutic device
* No other concurrent anticancer therapy
* No other concurrent investigational drugs or devices
* No concurrent drugs that would interact adversely with 5-FU or gemcitabine