Spots Global Cancer Trial Database for Sunitinib in Treating Patients With Metastatic Pancreatic Cancer That Progressed After First-Line Therapy With Gemcitabine

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Trial Identification

Brief Title: Sunitinib in Treating Patients With Metastatic Pancreatic Cancer That Progressed After First-Line Therapy With Gemcitabine

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

Study ID: NCT00397787

Conditions

Acinar Cell Adenocarcinoma of the Pancreas

Duct Cell Adenocarcinoma of the Pancreas

Recurrent Pancreatic Cancer

Stage IV Pancreatic Cancer

Interventions

sunitinib malate

Study Description

Brief Summary: 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.

Detailed Description: 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.