A phase III randomized, double-blind study of sunitinib (SU011248, sutent) versus placebo in patients with progressive advanced/ metastatic well-differentiated pancreatic islet cell tumors

For patients with neuroendocrine tumors there are little proven treatments
available. Besides the medicine Streptozocin there are no medicines registered
for patients with pancreatic islet cell tumors.
Previously performed phase 1 and 2 studies with this patient population
indicate that sunitinib could be a valuable treatment option for these patients.
These studies also showed that the safety and efficacy balalance was best at
37,5 mg.

To compare the progression-free survival (PFS) in subjects with pancreatic
islet cell tumors treated with sunitinib at a starting dose of 37.5 mg daily
(continuous dosing) with those treated with placebo.

This is a multi-center double-blind randomized phase 3 study with sunitinib
versus placebo in patients with pancreatic islet cell tumors. The patients will
be screened at least 21 days before the treatment with study medication. During
the screening several tests will be done. Thereafter the patients are in the
treatment phase. In this phase patients will be randomized 1:1 in sunitinib- or
placebo-group. The patients will then visit the hospital once every 4 weeks.
Patients will be treated until death or progression or final analysis
(endpoints).
Patients will be followed-up till 5 years or death once every 8 weeks via
telephone for their 'survival follow-up'.

Sunitinib 37.5 mg (can be adjusted to 25 mg or 50 mg) or placebo, daily for 1
year.

Patients will undergo several tests like physical examination, CT-scan chest,
abdomen, pelvis, bone and brain, bloodsample, ECG, MUGA/ECG. Also
questionaaires will have to be completed by the patient before any intervention
on each visit (1 x per 4 weeks).

The most common side effects from sunitinib are fatigue, weakness, nausea and
diarrhea.
Taking a bloodsample can cause inconvienience, pain, a little hematoma or
swelling on the location of sampling.