Bevacizumab and Gemcitabine Combined With Either Cetuximab or Erlotinib in Treating Patients With Advanced Pancreatic Cancer

Completed · Phase 2

Conditions studied: Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer

In brief

This randomized phase II trial is studying bevacizumab, gemcitabine, and cetuximab to see how well they work compared to bevacizumab, gemcitabine, and erlotinib in treating patients with advanced pancreatic cancer. Monoclonal antibodies, such as cetuximab and bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining bevacizumab and gemcitabine with either cetuximab or erlotinib may kill more tumor cells.

Key facts

Study ID

NCT00091026

Run by

National Cancer Institute (NCI)

People needed

143

Starts

2004-07-01

Expected to finish

2011-01-01

Last updated by the study team

2014-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• Advanced disease
• Patients with locally advanced disease must have disease that extends outside the boundaries of a standard radiation port
• Not amenable to curative surgery or radiotherapy
• Measurable disease
• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Pleural effusions and ascites are not considered measurable lesions
• No CNS disease, including primary brain tumors or brain metastasis
• No tumor invasion into the duodenum
• Performance status - ECOG 0-2
• More than 3 months
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• WBC ≥ 3,000/mm\^3
• No history of bleeding diatheses
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• SGOT and SGPT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
• INR ≤ 1.5 (≤ 3 for patients on warfarin)
• No esophageal varices
• Creatinine ≤ 1.5 mg/dL
• Creatinine clearance ≥ 60 mL/min
• Urine protein < 1+
• 24-hour urine protein < 500 mg
• No history of a recent cerebrovascular accident
• No clinically significant cardiovascular disease

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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