Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer
Completed · Phase 2
Conditions studied: Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer
In brief
This phase II trial is to see if combining gemcitabine with bevacizumab works in treating patients who have advanced pancreatic cancer. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill more tumor cells
Key facts
- Study ID
- NCT00028834
- Run by
- National Cancer Institute (NCI)
- People needed
- 50
- Starts
- 2002-02-01
- Last updated by the study team
- 2013-01-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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