Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage III Pancreatic Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Pancreas
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed pancreatic adenocarcinoma Not amenable to curative treatment with surgery or radiotherapy Locally advanced disease must extend outside the boundaries of a standard radiation port At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Pleural effusions and ascites not considered measurable lesions No obvious tumor involvement of major vessels on CT scan No known brain metastases Performance status - ECOG 0-2 More than 3 months WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No prior bleeding diathesis Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal PT INR no greater than 1.5 Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Urine protein less than 500 mg/24 hours if at least 1+ proteinuria No significant renal impairment No prior cardiovascular accident No prior deep vein thrombosis No myocardial ischemia or infarction within the past 6 months No uncompensated coronary artery disease within the past 6 months No uncontrolled hypertension No symptomatic congestive heart failure No cardiac arrhythmia No clinically significant peripheral artery disease No arterial thromboembolic event within the past 6 months, including any of the following: Transient ischemic attack Cerebrovascular accident Unstable angina Myocardial infarction No prior pulmonary embolism No concurrent uncontrolled illness No ongoing or active infection No other concurrent active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No psychiatric illness or social situation that would preclude study entry No prior allergic reaction attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents (Chinese hamster ovary cell products or other recombinant human antibodies) used in this study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior bevacizumab No prior cytotoxic chemotherapy for metastatic disease No prior gemcitabine At least 4 weeks since prior adjuvant chemotherapy and recovered At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to sole site of measurable disease At least 6 weeks since prior major surgery At least 30 days since prior investigational agents At least 1 month since prior and no concurrent thrombolytic agents or full-dose anticoagulants (except to maintain patency of pre-existing permanent indwelling IV catheters) No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function No other concurrent investigational agents No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent anticancer therapy
Sites / Locations
- University of Chicago Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (gemcitabine hydrochloride, bevacizumab)
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.