Gemcitabine, Cisplatin, and Bevacizumab in Treating Patients With Metastatic Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage IV pancreatic cancer
Eligibility 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
Sites / Locations
- UCSF Comprehensive Cancer Center