Gemcitabine, Cisplatin, and Bevacizumab in Treating Patients With Metastatic Pancreatic Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed adenocarcinoma of the pancreas
• •* Must have documented extrapancreatic metastases
• •* Radiographically measurable disease is not required
• •Previously untreated disease
• •No CNS or brain metastases
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •ECOG 0-2
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa \[Epogen®\] support allowed)
• •No evidence of bleeding diathesis or coagulopathy
• •Hepatic
• •INR ≤ 1.5 (except for patients receiving full-dose warfarin)
• •Bilirubin ≤ 2.0 mg/dL
• •AST or ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
• •Renal
• •Creatinine ≤ 2.0 mg/dL
• •Urine protein:creatinine ratio ≤ 1
• •Cardiovascular
• •No New York Heart Association class II-IV congestive heart failure
• •No myocardial infarction or stroke within the past 6 months
• •No uncontrolled hypertension (i.e., blood pressure \> 160/110 mm Hg despite antihypertensive therapy)
• •No unstable angina
• •No unstable symptomatic arrhythmia requiring medication
• •* Patients with chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) are eligible
• •No peripheral vascular disease ≥ grade 2
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 6 months after completion of study treatment
• •No significant traumatic injury within the past 28 days
• •No serious non-healing wound, ulcer, or bone fracture
• •No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
• •No other serious systemic disease
• •No history of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would preclude study treatment
• •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
• •No prior therapy, including systemic or investigational therapy, for locally advanced or metastatic pancreatic cancer
• •* Treatment given in the adjuvant setting (e.g., radiotherapy and/or chemotherapy, given either concurrently or systemically) is not considered prior therapy provided progressive disease occurred \> 6 months after completion of prior treatment
• •Concurrent continuation of therapeutic doses of warfarin or low-molecular weight heparin allowed for pulmonary embolism, deep vein thrombosis, atrial fibrillation, or other clinical indications provided patients has been on a stable dose for ≥ 28 days with no further clotting or bleeding complications