Pancreatic Cancer Clinical Trial
Official title:
Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer: a Phase II Randomized Trial.
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the
tyrosine kinases needed for angiogenesis and cell growth. It is not yet known whether
sunitinib malate is effective as maintenance therapy in delaying tumor progression in
patients with metastatic pancreatic cancer who are progression-free after 6 months of
induction chemotherapy.
PURPOSE: This randomized phase II trial is studying sunitinib malate as maintenance therapy
to see how well it works compared with observation in avoiding tumor progression after
induction chemotherapy in patients with metastatic pancreatic cancer.
OBJECTIVES:
- Compare the 6-month progression-free survival of patients with metastatic pancreatic
cancer without progression after 6 months of induction chemotherapy treated with
sunitinib malate as maintenance therapy vs observation.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms:
- Arm I: Patients receive oral sunitinib malate once daily for up to 6 months in the
absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo observation only.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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