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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
oral sunitinib 37.5 mg daily
San Raffaele Scientific Institute
Milan, Italy
6-month progression-free survival
CT scan
Time frame: every 2 months during therapy; every 3 months thereafter
Response rate
CT scan
Time frame: every 2 months during therapy; every 3 months thereafter
Toxicity
outpatient visit
Time frame: monthly during therapy
OVERALL SURVIVAL
outpatient visit
Time frame: monthly
PROGRESSION-FREE SURVIVAL
CT scan
Time frame: every 2 months during therapy; every 3 months thereafter
endothelial circulating cells
Time frame: baseline + every 2 months during therapy until progression
pharmacogenomics
Time frame: baseline
pharmacokynetics
Time frame: after 2 months of therapy
pharmacodynamics
Time frame: baseline and every 2 months until progression
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.