Stage IV Pancreatic Cancer Clinical Trial
Official title:
A Phase II Study of Bortezomib in Combination With Carboplatin in Patients With Metastatic Pancreatic Cancer
This phase II trial is studying how well giving bortezomib together with carboplatin works in treating patients with metastatic pancreatic cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with carboplatin may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To evaluate overall survival (OS) at 6 months with the combination of bortezomib and
carboplatin in patients who previously received 1 prior regimen for metastatic pancreatic
cancer.
SECONDARY OBJECTIVES:
I. To evaluate the objective tumor response rate, the duration of response, time to tumor
progression, and overall survival.
II. To evaluate biological effects on peripheral blood mononuclear cells. III. To evaluate
the safety profile of this combination. IV. To evaluate archival tissue for
epithelial-to-mesenchymal transition (EMT) and E-cadherin and Zeb-1.
OUTLINE:
Patients receive bortezomib intravenously (IV) on days 1, 4, 8, and 11 and carboplatin
intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
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