An Open-Label, Non-Randomized, Multicenter, Two-Stage, Phase 2 Study of S-1 as 2 Line Therapy for Patients With Metastatic Pancreatic Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas

- Not amenable to curative radiotherapy or surgery

- Received first-line treatment with a gemcitabine-based regimen

- Measurable liver metastasis, defined as ≥ 1 unidimensionally measurable lesion ≥ 20
mm by conventional techniques OR ≥ 10 mm by spiral CT scan

- No symptomatic brain metastasis unless controlled by corticosteroids

- No uncontrolled ascites requiring drainage ≥ 2 times a week

- No leptomeningeal metastasis

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- Not specified

Hematopoietic

- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.0 g/dL

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- ALT and AST ≤ 2.5 times ULN (5 times ULN if due to liver metastases)

Renal

- Creatinine clearance ≥ 60 mL/min

Cardiovascular

- No myocardial infarction within the past 6 months

- No severe/unstable angina

- No New York Heart Association class III or IV congestive heart failure

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after
completion of study treatment

- Able to take oral medications

- No known hypersensitivity to fluorouracil

- No other active malignancies

- No known HIV- or AIDS-related illness

- No other severe acute or chronic medical condition, psychiatric condition, or
laboratory abnormality that would preclude study participation

- No chronic diarrhea, constipation (uncontrolled by laxatives), nausea, or vomiting

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent immunotherapy

- No concurrent biologic response modifiers

Chemotherapy

- See Disease Characteristics

- At least 2 weeks since prior first-line gemcitabine-based regimen

- No other concurrent chemotherapy

- No fluoropyrimidine-group antineoplastic drugs within 7 days after completion of
study treatment

Endocrine therapy

- See Disease Characteristics

- No concurrent endocrine therapy

Radiotherapy

- At least 2 weeks since prior radiotherapy

- No prior radiotherapy to a target lesion unless the following are true:

- There is evidence of progressive disease after radiotherapy

- Target lesion is not the only site of measurable disease

- No concurrent radiotherapy

Surgery

- Not specified

Other

- More than 30 days since prior investigational agents

- No prior second-line therapy

- No concurrent investigational agents

- No concurrent drugs that may interact with S-1, including any of the following:

- Sorivudine

- Uracil

- Cimetidine

- Leucovorin calcium

- Dipyridamole

- Allopurinol

- Phenytoin

- Flucytosine

- No concurrent enrollment in another clinical study

- No other concurrent anticancer therapy

- No flucytosine within 7 days after completion of study treatment