Stage IV Pancreatic Cancer Clinical Trial
Official title:
A Phase II Study of Sunitinib Malate (SU11248, NSC #736511, IND #74,019) in Patients With Previously Treated Pancreatic Adenocarcinoma With Measurable Metastatic Disease Following Progression on Front-Line Gemcitabine-Based Therapy
This phase II trial is studying how well sunitinib works in treating patients with metastatic pancreatic cancer that progressed after first-line therapy with gemcitabine. Sunitinib may stop the growth of pancreatic cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the response rate to sunitinib malate in patients with previously treated
metastatic pancreatic adenocarcinoma.
SECONDARY OBJECTIVES:
I. To determine the duration of response, progression-free survival and overall survival of
sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma.
II. To determine the safety of sunitinib malate in patients with previously treated
metastatic pancreatic adenocarcinoma.
OUTLINE: This is a multicenter, nonrandomized study.
Patients receive oral sunitinib malate daily on days 1-28. Treatment repeats every 6 weeks
in the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed every 3 months until 2 years from study
entry or until disease progression.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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