Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer (PACT-12)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer: a Phase II Randomized Trial.|
- 6-month progression-free survival [ Time Frame: every 2 months during therapy; every 3 months thereafter ]CT scan
- Response rate [ Time Frame: every 2 months during therapy; every 3 months thereafter ]CT scan
- Toxicity [ Time Frame: monthly during therapy ]outpatient visit
- OVERALL SURVIVAL [ Time Frame: monthly ]outpatient visit
- PROGRESSION-FREE SURVIVAL [ Time Frame: every 2 months during therapy; every 3 months thereafter ]CT scan
- 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 ]
|Study Start Date:||February 2008|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
No Intervention: observation
no therapy until progression
sunitinib until progression or for a maximum of 6 months
oral sunitinib 37.5 mg daily
Other Name: SUTENT
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967603
|San Raffaele Scientific Institute|
|Milan, Italy, 20132|
|Principal Investigator:||Michele Reni, MD||Istituto Scientifico H. San Raffaele|