Inclusion Criteria

DISEASE CHARACTERISTICS: Histologic or cytologic diagnosis of advanced (stage II or III)
or metastatic (stage IV) adenocarcinoma of the exocrine pancreas and not considered a
surgical candidate Measurable or unmeasurable disease

PATIENT CHARACTERISTICS: Age: Age greater than or equal to 18 years Performance status:
Karnofsky 70-100% Life expectancy: Expected survival greater than 12 weeks Hematopoietic:
No inadequate bone marrow function within 2 weeks prior to randomization as evidenced by
the following: Absolute neutrophil count less than 2000/mm3 Platelet count less than
100,000/mm3 Hepatic: No inadequate hepatic function within 2 weeks prior to randomization
as evidenced by the following: Total bilirubin greater than 1.5 times upper limit of
normal (ULN) AST or ALT greater than 3 times ULN (greater than 5 times ULN if liver
metastases is documented) Renal: No inadequate renal function within 2 weeks prior to
randomization as evidenced by the following: Creatinine clearance less than 50 mL/min
Other: Adequate IV access to receive gemcitabine infusion Capable of swallowing intact
study medication capsules Capable of giving informed consent Capable of following
instructions or having a daily caregiver who assumes responsibility for administering
study medication and completing medication diaries No life threatening illness (unrelated
to tumor) No women of childbearing potential unless using an acceptable method of
contraception, or who are pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior immunotherapy or biologic therapy may be
allowed, but must have been completed at least 1 month prior to randomization
Chemotherapy: No prior chemotherapy for advanced stage pancreatic cancer Fluorouracil
(with or without leucovorin calcium or interferon) given with radiation as a radiation
sensitizer may be allowed, but must have been completed at least 3 months prior to
randomization Endocrine therapy: Prior hormonal therapy may be allowed, but must have been
completed at least 1 month prior to randomization Radiotherapy: No radiation therapy
within 4 weeks prior to first treatment Surgery: See Disease Characteristics