A Phase 2 interventional study of sunitinib in Pancreatic Cancer, sponsored by IRCCS San Raffaele. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-01.
Sponsored by IRCCS San Raffaele · Phase 2, Interventional, and Treatment
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:
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms:
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.
This study's enrollment of 56 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Pathologically confirmed metastatic pancreatic adenocarcinoma
No progressive disease for ≥ 6 months since beginning of induction chemotherapy (irrespective of regimen and response: stable disease, partial response, or complete response) demonstrated by the following:
PATIENT CHARACTERISTICS:
None of the following conditions related to cardiac disease, failure, or vascular disease including any of the following:
PRIOR CONCURRENT THERAPY:
No prior antiangiogenesis drugs, including any of the following:
no therapy until progression
sunitinib until progression or for a maximum of 6 months
Drug: sunitinib
oral sunitinib 37.5 mg daily
Also known as: SUTENT
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 study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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IRCCS San Raffaele