Phase II Study of Everolimus Combined With Octreotide LAR to Treat Advanced GI NET

Everolimus has been developed following two administration regimens: weekly and daily. Phase I pharmacodynamic studies recommend doses of 50 mg weekly and 10 mg/daily, based on its toxicity and inhibitory effect of the mTOR pathway in tumours; although the inhibition of this pathway has been demonstrated, the knowledge of response prediction factors has not been developed, in part due to the very low responses found in the population in phase I studies. These factors can be better outlined in a phase II study, where patients who have received fewer previous treatments can respond better, and where the profile of responders and non-responders can be identified more easily.

Inclusion criteria

• Diagnosis of non-operable or metastatic non-functioning, well differentiated advanced GI NET, confirmed by cytology or histology. In case of liver metastasis, neuroendocrine tumours of unknown origin are accepted.
• Confirmation of diagnosis of neuroendocrine carcinoma of low to intermediate histology grade
• Radiologically documented disease progression within 12 months prior to inclusion in the study. If the patient received anticancer treatment within the past 12 months, disease progression must be documented by radiology during or after taking this medication
• Adequate bone marrow. liver and renal function

Exclusion criteria

• Previous treatment with mTOR inhibitors (sirolimus, temsirolimus, everolimus, deforolimus).
• Patients with any serious disease and/or an uncontrolled clinical condition
• Patients on chronic treatment with corticosteroids or any other immunosuppressive agent