Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage IV pancreatic cancer
Eligibility 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
Sites / Locations
- Roswell Park Cancer Institute
- Case Comprehensive Cancer Center