Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer

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