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

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