Multicenter, Open Label, Phase II Clinical Study of Gemcitabine, Capecitabine and Avastin in Pancreatic Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the pancreas meeting 1 of the following
criteria:

- Newly diagnosed or previously treated metastatic disease

- Unresectable disease

- No CNS or brain metastases

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- ECOG 0-1

Life expectancy

- More than 3 months

Hematopoietic

- Absolute neutrophil count > 1,500/mm^3

- WBC > 3,000/mm^3

- Platelet count > 100,000/mm^3

- Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed)

- No evidence of bleeding diathesis or coagulopathy

Hepatic

- Bilirubin < 2 mg/dL

- AST or ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases
are present)

- INR < 1.5 (except for patients receiving full-dose warfarin)

Renal

- Creatinine < 1.5 mg/dL

- No proteinuria OR

- Urine protein < 500 mg by 24-hour urine collection

- No clinically significant impairment of renal function

Cardiovascular

- No uncontrolled hypertension (blood pressure > 160/110 mm Hg on medication)

- No New York Heart Association class II-IV congestive heart failure

- No unstable symptomatic arrhythmia requiring medication

- Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal
supraventricular tachycardia) allowed

- No clinically significant grade II-IV peripheral vascular disease

- No arterial thromboembolic event within the past 6 months, including any of the
following:

- Transient ischemic attack

- Cerebrovascular accident

- Unstable angina

- Myocardial infarction

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other serious systemic disease

- No significant traumatic injury within the past 28 days

- No serious non-healing wound, ulcer, or bone fracture

- No history of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- More than 28 days since prior major surgery or open biopsy

- More than 7 days since prior fine needle aspirations or core biopsies

- No concurrent major surgery

Other

- More than 4 weeks since prior and no concurrent participation in any other
experimental drug study

- More than 12 months since prior adjuvant therapy

- No prior systemic therapy for metastatic disease