RAD001 Plus Octreotide Depot in Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma
Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
Summary
Objectives:
Primary endpoint:
-Assess the clinical activity of RAD 001 plus depot octreotide as defined by progression free
survival (PFS) duration defined by RECIST criteria in treated and untreated patients with
metastatic, unresectable low grade neuroendocrine carcinoma.
Secondary endpoints:
- Assess the progression free survival duration of patients with metastatic, unresectable
low grade neuroendocrine carcinoma treated with RAD 001 plus depot octreotide.
- Assess the safety of RAD 001 plus depot octreotide in patients with metastatic,
unresectable low grade neuroendocrine carcinoma.
- To determine the expression/phosphorylation status of the components of the mTOR
signaling pathway in the primary tumors, in order to determine whether these markers can
be used as predictors of sensitivity to the combination of RAD001 and octreotide.
- To determine the effect of the combination of RAD001 and octreotide on the expression
and phosphorylation of mTOR's targets in the accessible tumor tissue, in order to
identify potential pharmacodynamics markers of response to this drug combination.
- To observe the effects of treatment with RAD001 on plasma angiogenic biomarkers.