NCT00967603

Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer

Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer: a Phase II Randomized Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	sunitinib	oral sunitinib 37.5 mg daily

Timeline

• Start date: 2008-02-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2009-08-28
• Last updated: 2012-02-01

Locations

1 site across 1 country: Italy